Front Row Produce Grape Tomatoes packaged in 10-oz. plastic clamshell containers (12/case), Product of Mexico. The tomatoes are also packaged in 10-lb. bulk boxes labeled only with the pack/lot number and no other identifying information. Recall # F-0441-2012

10-oz. containers cases - 2310802, 2310405, and 2510401 (the lot number is only found on the cases, not on the retail packages.) 10-lb. bulk - 2310801

Front Row Produce LLC, Saint Louis, MO, by fax on November 26, 2011 and via telephone on November 29&30, 2011. Firm initiated recall is ongoing.

The product tested positive for Salmonella.

91/12/1-pt. clamshell container cases and 30/10-lb. bulk boxes

MO and IL

1) Race Trac brand, Chicken Quarter Pounder, 7.8 ounce packages. Recall # F-0442-2012;

 

2) Race Trac brand, Chicken Quarter Pounder with Tomatoes, 8.8 ounce packages. Recall # F-0443-2012;

 

3) Race Trac brand, Ham Quarter Pounder, 7.38 ounce packages. Recall # F-0444-2012;

 

4) Race Trac brand, Ham Quarter Pounder with Tomatoes, 9.05 ounce packages. Recall # F-0445-2012;

 

5) Race Trac brand, American Sub that have 10.17 ounce packages. Recall # F-0446-2012;

 

6) Race Trac brand, Turkey Quarter Pounder, 7.38 ounce packages. Recall #F-0447-2012;

 

7) Race Trac brand, Turkey Quarter Pounder with Tomatoes, 9.05 ounce packages. Recall # F-0448-2012

Sell Thru Dates 10/11/11-11/30/11

Flying Food Group, LLC, Lawrenceville, GA, by email and telephone on November 21, 2011 and a press release on December 3, 2011. FDA initiated recall is ongoing.

Product was found to be contaminated with Listeria monocytogenes.

808 units

GA

Raw Cheddar cheese is a aged product. It is vacuum packaged in clear plastic. A stick-on label on the back of the package reads: "864" The product is portioned in various weights, between .25 - .50 pounds. A stick-on label reads in part: "Raw Cheddar Raw Unpasteurized Whole Milk, Salt, Culture, Vegetable Rennet, r-BST free***Keep Refrigerated***Natural handcrafted cheese produced by the Jensen ladies." 864 This code refers to the actual consecutive batch number of cheese ever made at this firm since its beginning in 2004. Recall # F-0452-2012

None

Jensen Family Dairy and Creamery, LLC, Bow, WA, by telephone on November 7, 2011 and by press release on November 8, 2011. Washington initiated recall is ongoing.

The Washington State Department of Agriculture collected a surveillance sample of raw cheddar cheese and it was found positive for Listeria monocytogenes.

Approximately 34 pounds

WA

1) The butter is packaged in plastic tubs with a stick-on label on the lid that reads: "Northwest Mushroom Trio Butter Pasteurized cream, Lobster, Oyster and Chanerelle mushrooms, salt. keep refrigerated 4 oz. MILK Natural handcrafted cheese produced by the Jensen ladies." Code "767" is on the top label. It is a batch code. Recall # F-0453-2012;

 

2) The butter is packaged in plastic tubs with a stick-on label on the lid that reads: "Herbes de Provence Butter Pasteurized cream, Rosemary, Savory, Oregano, Basil, Thyme and salt. Keep Refrigerated 4 oz. MILK Natural handcrafted cheese produced by the Jensen ladies." The three digit code, 767, on the top label is a batch code. Code "767" is on the top label. It is a batch code. Recall # F-0454-2012;

 

3) The butter is in a single 15 pound box (plastic bag inside box) with a stick-on label that reads: Unsalted Farmstead Butter Pasteurized cream Keep Refrigerated, 15 lbs. MILK Natural handcrafted cheese produced by the Jensen ladies." The three digit code, 756, on the top label is a batch code. Recall # F-0455-2012

1) Use by 1/20/12 or 1/27/12;  

2) Use by 1/6/12 or Use by 1/27/12;

3) Use by 12/8/11

Jensen Family Dairy and Creamery, LLC, Bow, WA, by telephone on December 2, 2011 and by press release on December 3, 2011. Washington initiated recall is ongoing.

A surveillance sample of Northwest Mushroom Trio butter, collected and analyzed by the Washington State Department of Agriculture (WSDA), was found positive for Listeria monocytogenes.

1 - 15 lb case of Unsalted butter, 21 - 4 ounce containers of Herbes de Provence butter and 68 - 4 ounce containers of Northwest Mushroom Trio butter

WA

Assi Brand Korean Cake, item #20649D, Net Weight 8 oz. retail packages, 25 packages/case, packages labeled in part ***UPC 0 8165220649 1. Recall # F-0457-2012

None

Recalling Firm: Rhee Brothers Inc., Hanover, MD, by visit starting on December 3, 2011.

Manufacturer: Cho & Son Inc., Philadelphia, PA. New York initiated recall is ongoing.  

Product contains eggs which are undeclared on the label.

37 cases

CA, NY, VA, TN, OK, OH, NC, MN, MI. LA, KS, IN, FL, and AR

1) Fair Oaks Farms Fine Cheese, Cheddar, 4 YR, clear plastic package, ~ 0.5 lbs. Recall # F-0458-2012;

 

2) Fair Oaks Farms Fine Cheese, Habanera Havarti, clear plastic package, ~ 0.5 lbs. Recall # F-0459-2012;

 

3) Fair Oaks Farms Fine Cheese, Havarti, clear plastic package, ~ 0.5 lbs. Recall # F-0460-2012;

 

4) Fair Oaks Farms Fine Cheese, Havarti Pepper, clear plastic package, ~ 0.5 lbs. Recall # F-0461-2012;

 

5) Fair Oaks Farms Fine Cheese, Havarti Dill, clear plastic package, ~ 0.5 lbs. Recall # F-0462-2012;

 

6) Fair Oaks Farms Fine Cheese, Sweet Swiss, clear plastic package, ~ 0.5 lbs. Recall # F-0463-2012;

 

7) Fair Oaks Farms Fine Cheese, Veggie Havarti, clear plastic package, ~ 0.5 lbs. Recall # F-0464-2012;

 

8) Fair Oaks Farms Fine Cheese, Havarti Onion, clear plastic package, ~ 0.5 lbs. Recall # F-0465-2012;

 

9) Fair Oaks Farms Fine Cheese, Hickory Smoked Sweet Swiss, clear plastic package, ~ 0.5 lbs. Recall # F-0466-2012;

 

10) Fair Oaks Farms Fine Cheese, Aged Gouda, clear plastic package, ~ 0.5 lbs. Recall # F-0467-2012;

 

11) Fair Oaks Farms Fine Cheese, Asiago, clear plastic package, ~ 0.5 lbs. Recall # F-0468-2012;

 

12) Fair Oaks Farms Fine Cheese, Mozzarella, clear plastic package, ~ 0.5 lbs. Recall # F-0469-2012;

 

13) Fair Oaks Farms Fine Cheese, Calico, clear plastic package, ~ 0.5 lbs. Recall # F-0470-2012;

 

14) Fair Oaks Farms Fine Cheese, Cheddar Curd, clear plastic package, ~ 0.5 lbs. Recall # F-0471-2012;  

 

15) Fair Oaks Farms Fine Cheese, Cheddar-1 YR, clear plastic package, ~ 0.5 lbs. Recall # F-0472-2012;

 

16) Fair Oaks Farms Fine Cheese, Cheddar-2 YR clear plastic package, ~ 0.5 lbs. Recall # F-0473-2012;

 

17) Fair Oaks Farms Fine Cheese, Cheddar-3 YR clear plastic package, ~ 0.5 lbs. Recall # F-0474-2012;

 

18) Fair Oaks Farms Fine Cheese, Cheddar-5 YR clear plastic package, ~ 0.5 lbs. Recall # F-0475-2012;

 

19) Fair Oaks Farms Fine Cheese, Cheddar-Mild, clear plastic package, ~ 0.5 lbs. Recall # F-0476-2012;

 

20) Fair Oaks Farms Fine Cheese, Emmenthaler, clear plastic package, ~ 0.5 lbs. Recall # F-0477-2012;

 

21) Fair Oaks Farms Fine Cheese, Farmers, clear plastic package, ~ 0.5 lbs. Recall # F-0478-2012;

 

22) Fair Oaks Farms Fine Cheese, Lacy Swiss, clear plastic package, ~ 0.5 lbs. Recall # F-0479-2012;

 

23) Fair Oaks Farms Fine Cheese, Muenster, clear plastic package, ~ 0.5 lbs. Recall # F-0480-2012;

 

24) Fair Oaks Farms Fine Cheese, Provolone, clear plastic package, ~ 0.5 lbs. Recall # F-0481-2012;

 

25) Fair Oaks Farms Fine Cheese, Smoked Gouda, clear plastic package, ~ 0.5 lbs. Recall # F-0482-2012;

 

26) Fair Oaks Farms Fine Cheese, Butterkase, clear plastic package, ~ 0.5 lbs. Recall # F-0483-2012;

 

27) Fair Oaks Farms Fine Cheese, Gouda clear plastic package, ~ 0.5 lbs. Recall # F-0484-2012

No expiration, no code 

Recalling Firm: Fair Oaks Dairy Products, LLC, Fair Oaks, IN, by telephone and e-mail on December 5, 2011 and by press release on December 7, 2011.

Manufacturers: Land O Lakes Inc., Kiel, WI;  

Edelweiss Graziers Cooperative, Monticello, WI. Indiana initiated recall is ongoing.

Possible Listeria monocytogenes contamination.

23, 341.57 pounds (46, 782 packages)

IN, IL, and TX

1) Pangasinan Smoked Mackerel (Hasa Hasa); 6 oz plastic package (170 g) Product of the Philippines; Keep Chilled, Cook Before Serving. Recall # F-0495-2012;

 

2) Pangasinan Smoked Round Scad, (Tinapang Galunggong); 6 oz plastic package (170 g) Product of the Philippines; Keep Chilled, Cook Before Serving. UPC: 2239257451. Recall # F-0496-2012

None

Recalling Firm: Camtrade Enterprises, Inc., Union City, CA, by letter on November 5, 2011.

Manufacturer: Fitrite Inc., Quezon City, Philippines. Firm initiated recall is ongoing.  

Uneviscerated fish has the potential to be contaminated with Clostridium botulinum, a bacteria which can cause life-threatening illness or death.

1) 3 cases; 2) 27 cases

CA

1) Barbecue sauce packaged in 18 oz and 34 oz capacity glass bottles and 1 gallon plastic containers. Recall # F-0497-2012;

 

2) Japeno Barbecue sauce packaged in 18 oz and 34 oz capacity glass bottles and 1 gallon plastic containers. Recall # F-0498-2012

None

Herbadashery LLC, Casper, WY, by letters on November 25, 2011. Firm initiated recall is complete.

The firm's products do not include anchovies as a sub ingredient in the barbecue sauce ingredient statements. The anchovies are contained in the Worcestershire sauce used to manufacture the product.

1) 516 x 18 oz; 120 x 34 oz; 16 x 1 gallon; 2) 924 x 18 oz; 300 x 34 oz; 58 x 1 gallon

CA, CO, IA, ID, IN, KS, MI, MO, OR, SD, TX, WA, WI and WY

Rising Moon Organic Mediterranean Garlic & Herb Ravioli, 8 oz. frozen. Recall # F-0501-2012

Sell by Apr 05 2012 printed on front label

Recalling Firm: Blue Marble Brands, N Providence, RI, by letter on December 12, 2011 and by press release on December 14, 2011.  

Manufacturer: Carmel Food Group, Inc., Hayward, CA. Firm initiated recall is ongoing.

The product contains undeclared soy.

540 cases (6/cs)

US-Eastern & Central region

 

Hampton Farms Smooth Peanut Butter, 12 and 18 oz plastic jars, UPC: 8186400040 and 8186400042, Product numbers: 866, 878, 1274-A and 1275-A. Recall # F-0440-2012

Best Buy Dates: 9/27/2012, 9/30/2012, 10/01/2012 and 10/19/2012

Northhampton Peanut Co., Severn, NC, by email, telephone, and letter on November 23, 2011. FDA initiated recall is ongoing.

Product was not manufactured under Good Manufacturing Processes

154,656 lbs 

IL, MI, MO and NV

1) Product of Centroamerica El Puro Queso Duro Blando El Sabor Original de Tu Tierra Hard Cheese INGREDIENTS: Pasteurized Milk to 3% of FAT, Calcium, Chloride, Lactic Cultures, Curdle, and Salt. Net Wt/PESO NETO 16 oz (1 Lb.) 454 g. Recall # F-0449-2012;

 

2) Alumbrando al Mundo con el Sabor de tu Tierra Queso Emanuel Hard Cheese Net Wt/PESO NETO 16 oz (1 lb.) 454 g. INGREDIENTS: Pasteurized Milk to 3% of FAT, Calcium, Chloride, Lactic Cultures, Curdle, Salt. Keep Refrigerated. Recall # F-0450-2012;

 

3) Alumbrando al Mundo con el Sabor de tu Tierra Queso Rallado Grated Cheese Net Wt/PESO NETO 16 oz (1 lb.) 454 g; INGREDIENTS: Pasteurized Milk to 3% of FAT, Calcium, Chloride, Lactic Cultures, Curdle, Salt. Keep Refrigerated. Recall # F-0451-2012

No Codes

Emanuel Distributors, Irving, TX, by letter on November 15, 2011. Firm initiated recall is ongoing.

The firm's product declared unpasteurized milk as pasteurized milk on the ingredient statement and possible adverse health effects from pathogens that may survive a 66-day aging process in products made from unpasteurized milk.

 

248 units of the Queso Rallado (1 lb), 2500 units of the El Puro Queso Duro Blando (1 lb), and 2000 units of the Queso Emanuel Hard Cheese (1 lb)

AR and TX

365 Everyday Value Organic Cashews mislabeled as 365 Everyday Value Organic Walnuts halves & pieces; USDA ORGANIC NET WT 12 OZ (340g); Product would have shipped in a case for cashews. UPC: 0 99482 43428 1. Recall # F-0485-2012

Lot Code: 10/12/12

Recalling Firm: Whole Foods Market, Austin, TX, by e-mail on November 29, 2011.

Manufacturer: Golden Boy Foods Limited partnership, Burnaby, Canada. Firm initiated recall ongoing.  

Undeclared cashews. There are 365 Cashews which are mislabeled as 365 Organic Walnuts. The product would have shipped in a case for cashews.

1241 retail units

Nationwide and Canada

1) Cranberry Apricot Nut Crostini has a 9 oz (225 g) net weight. The UPC is 8 91886 00322 9. The product is labeled in part: "***MACRINA BAKERY***cranberry apricot nut crostini***Unbleached white wheat flour, natural sour starter, filtered water, dried unsulphured apricots, cranberries, pecans, walnuts, organic wheat flour, salt, anise, cloves, olive oil, garlic, contains wheat***". Recall # F-0486-2012;

 

2) Herb Wheat Walnut Crostini has a 9 oz (225 g) net weight. The UPC is 8 91886 00321 2. The product is labeled in part: "***MACRINA Bakery Cafe***HERB WHEAT WALNUT CROSTINI***Unbleached white wheat flour, natural sour starter, filtered water, walnuts, organic whole wheat flour, assorted fresh herbs (parsley, thyme, rosemary, sage, oregano), olive oil, garlic, contains wheat***". Recall # F-0487-2012

Sell By 11/18 through 12/2

Mac & Co. dba Macrina Bakery and Café, Seattle, WA, by telephone on November 22, 2011. FDA initiated recall is ongoing.

Product contains walnut and it is declared in the Ingredient Statement. However, walnut is not declared in the Contains allergen statement.

359 - 9 ounce bags of Cranberry apricot nut crostinis and 34 - 9 ounce bags of Herb wheat walnut crostinis

WA

1) Seafood salad, under the brand name: Noelle's . Product labeling reads in part: "SEAFOOD SALAD Ingredients: Imitation Crab, Mayonnaise***Net Weight 5lb ***0 87709 01840 6. Recall # F-0488-2012;

 

2) Linguine/Artichoke Salad, under the brand name: Noelle's. Product labeling reads in part: "LINGUINE/ARTICHOKE SALAD INGREDIENTS: Rotini Pasta, Linguine Pasta***Mayonnaise***Net Weight 5lb ***0 87709 01869 7. Recall # F-0489-2012

None

Nasco Gourmet Foods, Corona, CA, by letters via combination of email, visit, and telephone, on December 8, 2011. FDA Initiated recall is ongoing.

During a FDA inspection of the firm, it was discovered that the firm's products contained undeclared soybean oil in a sub-ingredient.

197 units

CA

Strawberry Cakes. Product is sold under brand name Pander El Angel. Individual piece of strawberry cake are wrapped as a single unit in a transparent plastic container. Each unit is approximately 7 inches by 7 inches and weight approximately 1 pound. There is no UPC on package. The product is labeled in parts: "***Pastel 3 Leches***Milk Egg, Sugar, Flour, Royal, Oil, Conservatives, Chantilli. Recall # F-0490-2012;

None

Panaderia El Angel, Arlington, WA, by visit on December 2, 2011. FDA initiated recall is ongoing.

Assorted Mexican Pastries contain undeclared FD&C Red No. 3.

576 units

WA

1) Dell'Alpe Sport Peppers; packaged in an 8 fl. oz. (236 mL) glass jar, 12 jars per case; UPC 0 75462 02033 0. Recall # F-0492-2012;

 

2) Vienna Sport Peppers; packaged in a 12 fl. oz. (355 mL) glass jar, 12 jars per case; UPC 0 70723 55252 0. Recall # F-0493-2012

1) All jars with a four digit code on the front panel of the label;

2) Best By dates 012810 through 100413

Rubinelli Inc., Bolingbrook, IL, by fax on November 14, 2011 and follow-up letters on November 17, 2011. Firm initiated recall is ongoing.

The sport peppers contain undeclared color - FD&C Yellow #5 which is not declared on the label.

22,128 cases

CA, IL, IN, WI

Vitamin E Oil, UPC 005368533962 --- Uses: Moisturizes and conditions by helping to restore the skin's essential nutrients. Each 5 drops supplies 100 International Units of Vitamin E in a natural base of heat germ and vegetable oils. Recall # F-0499-2012

Lot codes: 601673, 603717, 605603, 901284, 801284, 802284

Hi-Tech Pharmacal Co., Inc., Amityville, NY, by letter on September 10, 2010 and September 22, 2010. Firm initiated recall is ongoing.

Vitamin E Oil was recalled as it did not meet the specifications for microbial limits, specifically for yeast and mold.

47,172 bottles

GA

Maruchan Ramen Noodle Soup, Picante Beef Flavor, Net Wt. 3 oz (85g). 24 packages per case. Recall #F-0500-2012

Lot #040313 AV, 040313 BV, 040313 CV

Recalling Firm: Maruchan, Inc., Irvine, CA, by letter on November 9, 2011

Manufacturer: Maruchan Virginia Inc., Richmond, VA. Firm initiated recall is ongoing.

The Ramen Noodle Soup Picanted Beef Flavor contains an incorrect flavor, Picante Chicken, which has dehydrated celery stalk.

5,304 cases

TN, MI, GA, MO, and FL

 

Assorted Mexican Pastries and Cookies with red frosting and/or gel. Product is sold under brand name Panaderia El Angel. Pastries are distributed in bulk on a metal tray wrapped with cellophane. Each tray contains 50 units total but 4 units contain and are observed with a red-pink color frosting and 3 units are observed with a red-pink color filling gel. Trays are distributed to consignees without an affixed label. A label is provided to the consignee separately and then it is placed on the bakery display case. There is no net quantity nor UPC on the label. The product is labeled in parts: "***Wheat flour bleached & unbleached granulated, Vegetable bakes margarine (non-dairy), all purpose shortening, partially hydrogenated soybean oil, sugar, water, salt, margarine (partially hydrogenated), vegetable shortening***, eggs, 2% milk, butter, soy bean oils, yeast, melted barley flour***Yellow (5), Yellow (6) Citric Acid, ***artificially colored with beta-carotene. Recall # F-0491-2012

None

Panaderia El Angel, Arlington, WA, by visit on December 2, 2011. FDA initiated recall is ongoing.

Assorted Mexican Pastries and Cookies contain undeclared FD&C Red No. 3.

9,800 units

WA

Mother Murphy's Natural Pina Colada Flavor, 1 gallon, 2114490-1G. Recall # F-0494-2012

Lot numbers: 234738, 237035, 238814, 240725, 239480, 239985 and 241061

Mother Murphy’s Laboratory, Greensboro, NC, by e-mail on December 16, 2011. Firm initiated recall is ongoing.

The product does not list coconut as an ingredient; however, there is allergy information on the label.

95 gallons

TX

 

 

 

 

 

 

 

 

 

 

 

 

Red Blood Cells Leukocytes Reduced. Recall # B-0299-12

W0423110016433

Recalling Firm: Blood Systems, Inc., Billings, MT, by electronic notification on October 24, 2011 and by letter dated November 15, 2011.

Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

1 unit

Switzerland, CA

SoftBank II versions: 23.0, 23.1, 23.2, 25.0, 25.1 when used with SoftScape GUI versions: 1.2.0.7 - 1.2.0.15 and 1.3.0.4 - 1.3.0.5. Recall # B-0321-12

SoftBank II versions: 23.0, 23.1, 23.2, 25.0, 25.1

SCC Soft Computer, Clearwater, FL, through SCC Soft Computer's proprietary Task Management System on May 9, 2011. Firm initiated recall is ongoing.

SCC Soft Computer, SoftBank II versions: 23.0, 23.1, 23.2, 25.0, 25.1 when used with SoftScape GUI versions: 1.2.0.7, 1.2.0.15 and 1.3.0.4, 1.3.0.5, with a glitch or defect, were distributed.

136

Nationwide and Canada

SoftBank II versions: 23.2.0.1-23.2.0.5, 25.0.0.3-25.0.0.5, and 25.1.0.1-25.1.0.2. Recall # B-0322-12

SoftBank II versions: 23.2.0.1-23.2.0.5, 25.0.0.3-25.0.0.5, and 25.1.0.1-25.1.0.2

SCC Soft Computer, Clearwater, FL, through SCC Soft Computer's proprietary Task Management System on September 16th, 2011. Firm initiated recall is ongoing

SCC Soft Computer, SoftBank II versions: 23.2.0.1-23.2.0.5, 25.0.0.3-25.0.0.5, and 25.1.0.1-25.1.0.2, with a glitch or defect, were distributed.

59 units

Nationwide and Canada

 

Recovered Plasma. Recall # B-0298-12

W0423110016433

Recalling Firm: Blood Systems, Inc., Billings, MT, by electronic notification on October 24, 2011 and by letter dated November 15, 2011.

Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

1 unit

Switzerland, CA

1) Cancellous Particles: "***PUROS ALLOGRAFT augmentation material***REF***Cancellous Particles***Rx only*** STERILE***". All sizes are subject to recall: REF 68209 - Cancellous Particles W= 0.25 - 1 mm Qty 2.0 cc RTI: ZCN012 REF 68210 - Cancellous Particles W= 0.25 - 1 mm Qty 0.5 cc RTI: ZCN010 REF 68211 - Cancellous Particles W= 0.25 - 1 mm Qty 1.0 cc RTI: ZCN011 REF 68212 - Cancellous Particles W= 1-2 mm Qty 0.5 cc RTI: ZCN020 REF 68213 - Cancellous Particles W= 1-2 mm Qty 1.0 cc RTI: ZCN021 REF 68214 - Cancellous Particles W= 1-2 mm Qty 2.0 cc RTI: ZCN022. Recall # B-0369-12;

 

2) Cortical Particles: "***PUROS ALLOGRAFT augmentation material***REF***Cortical Particles***Rx only***STERILE***". All sizes subject to recall: REF 68271 - Cortical Particles W= 0.25 - 1 mm Qty 0.5 cc RTI: ZCR010 REF 68272 - Cortical Particles W= 0.25 - 1 mm Qty 1.0 cc RTI: ZCR011 REF 68273 - Cortical Particles W= 0.25 - 1 mm Qty 2.0cc RTI: ZCR012 REF 68274 - Cortical Particles W= 1 - 2 mm Qty 0.5 cc RTI: ZCR020 REF 68275 - Cortical Particles W= 1 - 2 mm Qty 1.0cc RTI: ZCR021 REF 68276 - Cortical Particles W= 1 - 2 mm Qty 2.0cc RTI: ZCR022. Recall # B-0370-12

1) All sizes. Label ID: 9797725 9797726 9797728 9797727 9797718 9797715 9797716 9797717 9797719 9797714 9797720 9797721 9797722 9797723 9797442 9797443 9797444 9797445 9797446 9797447 9797448 9797481 9797497 9797498 9797499 9797500 9797512 9797518 9797546 9797574 9797533 9797534 9797535 9797536 9797459 9797496 9797549 9797550 9797551 9797554 9797555 9797564 9797567 9797568 9797455 9797456 9797457 9797458 9797469 9797553 9797486 9797487 9797488 9797489 9797490 9797517 9797449 9797532 9797474 9797495 9797484 9797485 9797521 9797572 9797479 9797470 9797477 9797541 9797542 9797543 9797471 9797472 9797478 9797480 9797491 9797492 9797493 9797494 9797515 9797516 9797537 9797461 9797475 9797476 9797514 9797531 9797462 9797463 9797464 9797465 9797466 9797467 9797468 9797509 9797510 9797519 9797522 9797523 9797524 9797525 9797526 9797527 9797528 9797529 9797530 9797520 9797538 9797539 9797483 9797502 9797503 9797504 9797505 9797506 9797507 9797508 9797544 9797570 9797451 9797452 9797453 9797454 9797573 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9796358 9796359 9796360 9796361 9796362 9796363 9796364 9796365 9796366 9796367 9796368 9796369 9796370 9796371 9796372 9796373 9796374 9796375 9796376 9796377 9796378 9796379 9796380 9796381 9796382 9796383 9796384 9796385 9796386 9796387 9796388 9796389 9796390 9796391 9796392 9796393 9796394 9796395 9796396 9796397 9796398 9796399 9796400 9796401 9796402 9796403 9796404 9796405 9796406 9796407 9796408 9796409 9796410 9796411 9796412 9796413 9796414 9796415 9796416 9796417 9796418 9796419 9796420 9796421 9796422 9796423 9796424 9796425 9796426 9796427 9796428 9796429 9796430 9796431 9796432 9796433 9796434 9796435 9796436 9796437 9796438 9796439 9796440 9796441 9796442 9796443 9796444 9796445 9796446 9796447 9796448 9796449 9796450 9796451 9796452 9796453 9796454 9796455 9796456 9796457 9796458 9796459 9796460 9796461 9796462 9796463 9796464 9796465 9796466 9796467 9796468 9796469 9796470 9796471 9796472 9796473 9796474 9796475 9796476 9796477 9796478 9796479 9796480 9796481 9796482 9796483 9796484 9796485 9796486 9796487 9796488 9796489 9796490 9796491 9796492 9796493 9796494 9796495 9796496 9796497 9796498 9796499 9796500 9796501 9796502 9796503 9796504 9796505 9796506 9796507 9796508 9796509 9796510 9796511 9796512 9796513 9796514 9796515 9796516 9796517 9796518 9796519 9796520 9796521 9796522 9796523 9796524 9796525 9796526 9796527 9796528 9796529 9796530 9796531 9796532 9796533 9796534 9796535 9796536 9796537 9796538 9796539 9796540 9796541 9796542 9796543 9796544 9796545 9796546 9796547 9796548 9796549 9796550 9796551 9796552 9796553 9796554 9796555 9796556 9796557 9796558 9796559 9796560 9796561 9796562 9796563 9796564 9796565 9796566 9796567 9796568 9796569 9796570 9796571 9796572 9796573 9796574 9796575 9796576 9796577 9796578 9796579 9796580 9796581 9796582 9796583 9796584 9796585 9796586 9796587 9796588 9796589 9796590 9796591 9796592 9796593 9796594 9796595 9796596 9796597 9796598 9796599 9796600 9796601 9796602 9796603 9796604 9796605 9796606 9796607 9796608 9796609 9796610 9796611 9796612 9796613 9796614 9796615 9796616 9796617 9796618 9796619 9796620 9796621 9796622 9796623 9796624 9796625 9796626

RTI Biologics, Inc., Alachua, FL, by letter the week of July 26, 2010 and July 27, 2010. Firm initiated recall is complete.

Bone allografts, packaged with a lack of assurance of sterility, were distributed.

9,011 units

Nationwide, PR, Canada, and Latin America

LABScreen MICA Single Antigen-Group 1; Product Number: LSMICA001. Recall # B-0402-12

Lot number 002, 003, 004 Expiration Date: 06/2008, 08/2011, 07/2013

One Lambda Inc., Canoga Park, CA, by letter on July 18, 2011. Firm initiated recall is ongoing.

LABScreen MICA Single Antigen - Group 1, in which a false reaction may be observed with the MICA19 antigen, was distributed.

390 units

Nationwide, Canada, Saudi Arabia, Egypt, United Kingdom, France, Germany, Greece, Italy, Bosnia Herzegovina, Austria, Netherlands, Korea, Spain, China, India, Japan, Mexico, Philippines, and Taiwan

 

1) SKYLight Gamma Camera System; SKYLIGHT 8 FT, 3/8" SPECT. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2161-3000A. Recall # Z-0247-2012;

 

2) SKYLight Gamma Camera System; SKYLIGHT 8 FT, 5/8" SPECT. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2161-3001A. Recall # Z-0248-2012;

 

3) SKYLight Gamma Camera System; SKYLIGHT, 3/8", SPECT. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2160-3000A 4535-600-66661. Recall # Z-0249-2012;

 

4) SKYLight Gamma Camera System; SKYLIGHT, 5/8", SPECT; The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2160-3001A. Recall # Z-0250-2012;

 

5) SKYLight Gamma Camera System; SKYLIGHT, AZ, 8 FT, 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2161-3000B 4535-602-46831. Recall # Z-0251-2012;

 

6) SKYLight Gamma Camera System; SKYLIGHT, AZ, 8 FT, 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2161-3001B 4535-602-55271. Recall # Z-0252-2012;

 

7) SKYLight Gamma Camera System; SKYLIGHT, AZ, 9 FT, 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2160-3000B, 4535-602-46641. Recall # Z-0253-2012;

 

8) SKYLight Gamma Camera System; SKYLIGHT, AZ, 9 FT, 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2160-3001B. Recall # Z-0254-2012;

 

9) Precedence System; SYST, PRECEDENCE, 16 Slice 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3001A 4535-602-50861. Recall # Z-0255-2012;

 

10) Precedence System; SYST, PRECEDENCE, 16 Slice 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3000A 4535-602-50851. Recall # Z-0256-2012;

 

11) Precedence System; SYST, PRECEDENCE, 6 Slice 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3002A 4535-602-53551. Recall # Z-0257-2012;

 

12) Precedence System; SYST, PRECEDENCE, 6 Slice 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3003A 4535-602-53561. Recall # Z-0258-2012

None

Recalling Firm: Philips Medical Systems, San Jose, CA, by letter dated September 27, 2011. 

Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Firm Initiated recall is ongoing.

A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.

658

Nationwide and Internationally

"***UPLIFT TECHNOLOGIES INC.***Bringing quality to life.***Model No.***CA200***Description***Lifting commode chair***Weight Range***80-300+ lb-136+ kg***" Labeling on product: "***1C0101 and K0061014***". A lifting commode chair that is self-powered (non-electric) and provides lifting assistance for those who have reduced mobility due to arthritis, post-operative conditions, degenerative joint disease, Parkinson's disease or other neuromuscular disorders. Recall # Z-0270-2012

Lot No. 1C0101

Recalling Firm: Uplift Technologies Inc., Dartmouth, Canada, by fax, telephone or letter dated June 27, 2011.

Manufacturer: Maxhealth Corp., Taipei, Taiwan. FDA initiated recall is ongoing.  

The plastic seat does not meet manufacturing specifications. The seat may not fit the unit properly and may interfere with the unit's normal locking mechanism.

219 units

Nationwide and Canada

1) Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-H63. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device. Recall #Z-0329-2012;

 

2) Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device. Recall # Z-0330-2012

1) H630164 H630703 H630727 H630756 H630787 H630810 H630829 H630850 H630868 H630888 H630165 H630705 H630728 H630757 H630789 H630811 H630832 H630851 H630869 H630889 H630168 H630706 H630729 H630758 H630790 H630812 H630833 H630852 H630870 H630891 H630170 H630711, H630732 H630760 H630792 H630813 H630834 H630854 H630871 H630892 H630205 H630712 H630733 H630764 H630793 H630814 H630835 H630855 H630872 H630895 H630206 H630713 H630736 H630769 H630794 H630815 H630837 H630857 H630877 H630896 H630210 H630714 H630737 H630771 H630795 H630817 H630839 H630858 H630878 H630897 H630211 H630716 H630739 H630774 H630798 H630818 H630841 H630859 H630879 H630898 H630214 H630718 H630741 H630776 H630801 H630820 H630842 H630860 H630880 H630901 H630215 H630719 H630744 H630777 H630802 H630822 H630843 H630863 H630881 H630902 H630216 H630720 H630747 H630778 H630804 H630825 H630845 H630864 H630884 H630903 H630219 H630721 H630749 H630781 H630807 H630826 H630847 H630866 H630885 H630904 H630701 H630722 H630753 H630784 H630809 H630828 H630848 H630867 H630886;

 

2) Units: H630164 H630703 H630727 H630756 H630787 H630810 H630829 H630850 H630868 H630888 H630165 H630705 H630728 H630757 H630789 H630811 H630832 H630851 H630869 H630889 H630168 H630706 H630729 H630758 H630790 H630812 H630833 H630852 H630870 H630891 H630170 H630711 H630732 H630760 H630792 H630813 H630834 H630854 H630871 H630892 H630205 H630712 H630733 H630764 H630793 H630814 H630835 H630855 H630872 H630895 H630206 H630713 H630736 H630769 H630794 H630815 H630837 H630857 H630877 H630896 H630210 H630714 H630737 H630771 H630795 H630817 H630839 H630858 H630878 H630897 H630211 H630716 H630739 H630774 H630798 H630818 H630841 H630859 H630879 H630898 H630214 H630718 H630741 H630776 H630801 H630820 H630842 H630860 H630880 H630901 H630215 H630719 H630744 H630777 H630802 H630822 H630843 H630863 H630881 H630902 H630216 H630720 H630747 H630778 H630804 H630825 H630845 H630864 H630884 H630903 H630219 H630721 H630749 H630781 H630807 H630826 H630847 H630866 H630885 H630904 H630701 H630722 H630753 H630784 H630809 H630828 H630848 H630867 H630886

Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated October 6, 2011. Firm initiated recall is ongoing.

The Product Models 1 & 2 has a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.

129 units

Nationwide and Internationally

Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System. These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table. This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities. Recall # Z-0331-2012

Last Four Digits of Lot #2408, 2064, 2851, 2076, 2081, 2804, 2109, 2100, 2519, 2521, 2008, 3063, 2537, 2350, 2382, 2834, 3030, 3043, 3250, 3194, 2105, 2938, 2063, 2148, 2187, 2313, 2324, 2330, 2331, 2424, 2284, 2692, 2067, 2416, 2802, 3294, 2846, 2852, 2901, 3011, 3075, 3167, 2590, 2591, 2462, 3044, 2305, 3155, 3066, 3102, 3290, 3188, 2176, 2781, 3293, 2117, 3308, 3309, 2862, 2321, 2225, 2235, 2238, 3041, 7003, 7004, 2502, 2599, 3317, 2246, 2272, 2217, 3330, 3048, 2954, 3341, 2391, 2835, 2557, 2303, 2294, 2440, 2348, 2597, 3003, 2369, 2500, 2070, 2613, 2299, 2301, 2216, 3146, 3166, 3110, 2262, 2040, 2675, 3064, 2097, 2145, 3203, 2870, 2306, 2750, 2776, 2691, 2410, 7005, 2930, 2494, 2052, 2244, 2245, 2457, 3345, 2683, 2152, 2995, 2970, 2816, 2763, 2593, 2708, 2674, 2744, 2547, 2966, 2967, 2730, 2836, 2843, 2844, 2845, 2643, 2751, 2261, 2373, 2697, 2559, 2405, 2565, 3189, 2121, 3134, 2821, 3195, 2157, 2158, 2206, 3193, 3285, 3350, 2841, 2401, 2503, 2863, 2534, 2140, 2530, 3355, 3262, 3307, 2581, 2736, 2982, 2418, 2280, 2281, 3149, 2353, 2456, 2346, 2349, 2091, 2343, 3213, 2815, 2857, 2909, 2973, 3049, 3047, 2544, 2688, 3060, 2315, 2308, 2676, 2961, 3176, 2760, 3187, 2267, 2504, 2908, 2738, 2007, 3156, 3373, 3380, 2354, 2524, 2190, 2250, 3173, 3197, 3349, 2470, 2178, 2174, 2785, 3022, 3371, 3108, 2394, 3352, 2383, 2824, 2574, 2659, 2789, 2782, 2788, 2498, 2614, 2975, 2398, 3150, 2620, 2752, 3319, 2445, 2501, 2837, 2737, 2801, 2194, 2213, 2513, 2558, 2957, 2984, 2204, 3123, 2395, 2478, 2595, 2921, 3325, 2399, 3074, 3087, 3181, 2900, 2538, 3314, 2082, 3236, 2814, 2095, 3200, 3055, 3056, 2022, 3178, 2310, 3093, 2198, 2096, 2268, 3305, 2952, 2628, 2994, 2427, 2655, 2989, 2374, 2447, 3378, 3198, 3346, 2362, 2455, 2721, 3261, 2423, 2439, 2569, 2682, 3177, 3233, 2104, 2871, 2876, 2073, 2316, 2128, 3336, 3427

Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter dated October 3, 2011. 

Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.  

The recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop. The result of the tabletop rotating unexpectedly is the patient being transferred may fall from the tabletop.

300 units

Nationwide

Model H48: Head Ring Posts with part number 970.280 - re-usable components of the Frame Array Module (of the Optical Guidance Platform and Floor stand devices. The Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment for stereotactic radiosurgery or radiotherapy treatments on cranial extracranial lesions. Recall # Z-0332-2012

Code numbers: HZ50004 HZ70169 HZ70426 HZ70617 HZ70743 HZ72001 HZ72037 HZ72064 HZ72089 HZ73039 HZ77007 HZ50468 HZ70181 HZ70460 HZ70620 HZ70762 HZ72002 HZ72038 HZ72067 HZ72090 HZ73041 HZ77010 HZ50567 HZ70182 HZ70465 HZ70629 HZ71001 HZ72003 HZ72039 HZ72068 HZ72091 HZ73042 HZ77011 HZ50671 HZ70190 HZ70466 HZ70640 HZ71002 HZ72004 HZ72040 HZ72069 HZ72094 HZ73044 HZ77027 HZ59006 HZ70223 HZ70486 HZ70646 HZ71003 HZ72005 HZ72041 HZ72070 HZ72095 HZ73046 HZ77040 HZ59011 HZ70231 HZ70495 HZ70649 HZ71004 HZ72006 HZ72042 HZ72071 HZ72096 HZ73047 HZ77062 HZ59014 HZ70258 HZ70500 HZ70656 HZ71005 HZ72007 HZ72043 HZ72072 HZ72098 HZ73049 HZ77069 HZ59016 HZ70273 HZ70507 HZ70670 HZ71006 HZ72008 HZ72046 HZ72073 HZ72101 HZ73050 HZ77077 HZ59017 HZ70274 HZ70508 HZ70674 HZ71007 HZ72009 HZ72047 HZ72074 HZ72103 HZ73053 HZ77081 HZ59018 HZ70283 HZ70509 HZ70675 HZ71008 HZ72012 HZ72048 HZ72075 HZ72107 HZ73055 HZ78330 HZ59020 HZ70293 HZ70513 HZ70681 HZ71009 HZ72013 HZ72049 HZ72077 HZ72108 HZ73059 HZ79012 HZ59139 HZ70294 HZ70537 HZ70684 HZ71011 HZ72015 HZ72052 HZ72080 HZ72125 HZ73060 HZ79020 HZ59997 HZ70299 HZ70540 HZ70696 HZ71013 HZ72016 HZ72054 HZ72081 HZ72126 HZ73062 HZ79113 HZ59998 HZ70351 HZ70548 HZ70698 HZ71014 HZ72023 HZ72055 HZ72082 HZ72190 HZ73064 HZ79144 HZ70044 HZ70355 HZ70550 HZ70703 HZ71017 HZ72026 HZ72056 HZ72083 HZ73020 HZ75070 HZ79185 HZ70050 HZ70368 HZ70557 HZ70712 HZ71019 HZ72027 HZ72057 HZ72084 HZ73021 HZ75480 HZ79998 HZ70061 HZ70398 HZ70585 HZ70725 HZ71021 HZ72029 HZ72058 HZ72085 HZ73022 HZ76066 HZ70083 HZ70403 HZ70594 HZ70731 HZ71022 HZ72030 HZ72060 HZ72086 HZ73026 HZ76118 HZ70108 HZ70404 HZ70603 HZ70737 HZ71023 HZ72033 HZ72061 HZ72087 HZ73030 HZ77002 HZ70154 HZ70405 HZ70612 HZ70740 HZ71024 HZ72036 HZ72062 HZ72088 HZ73031 HZ77003

Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated October 4, 2011. Firm initiated recall is ongoing.

An anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failure during usage.

205 Kits (each kit contains 4 Head Ring Posts or 820 HRP's

Nationwide and Internationally

LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office follow-ups. The software version affected domestically is version 1.05 for COGNIS and TELIGEN and internationally is version 2.04 for COGNIS, TELIGEN, and PUNCTUA, ENERGEN, and INCEPTA. The PUNCTUA, ENERGEN, and INCEPTA are not currently approved in the US. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. The LATITUDE Patient Management System software is web-based and therefore at any point in time, there is only one (1) released version for each model number. The current version is 7.1. Both the programmer software and the LATITUDE remote monitoring system software similarly display the shock lead impedance measurements. Recall # Z-0333-2012

domestically is version 1.05; internationally is version 2.04; version 7.1

Boston Scientific CRM Corp., Saint Paul, MN, by letter dated October 2011.  Firm initiated recall is ongoing.

Current Boston Scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and LATITUDE monitoring system via the Daily Measurements feature. A measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a Red Alert within LATITUDE (if activated). However, the measured value that prompted the alert is not displayed. Similarly, out-of-range impedance measurements are not plotted on programmer or LATITUDE trending graphs. Boston Scientific has received reports that, in some instances, this has made it more difficult for physicians to troubleshoot the system and determine whether the out-of-range impedance value truly reflected an underlying lead/system issue.

25,300 (14,700 Nationwide, 10,600 Internationally)

Nationwide and Internationally

1) Dual Incu i (Atom Infant Incubator Model 100). Usage: A combination incubator and warmer for infants. Recall #Z-0337-2012;

 

2) Incu i (Atom Infant Incubator Model 101). Usage: An incubator for infants. Recall #Z-0338-2012;

 

3) Rabee Incu i (Atom Infant Incubator Model 102). Usage: An incubator for infants. Recall #Z-0339-2012;

 

4) Infa Warmer i (Atom Infant Warmer Model 103). Usage: A warmer for infants. Recall # Z-0340-2012

All lots on the market.

Atom Medical Corp., Bunkyo-Ku, Japan, by letter dated August 18, 2011. Firm initiated recall is ongoing.

The caster with lock on the radiant-warming open type incubator may become loose or break.

453 Units

Nationwide and Internationally

Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy treatment process. Recall # Z-0342-2012

Units: G30369, G29103, G34727, G32313, G30367, G29101, G31330, G34401, G32304, G30962, G30610, G30668, G29986, G28427, G28581, G28673, G28430, G28755, G28576, G28574, G28676, G28678, G28811, G28763, G28806, G28863, G28809, G28864, G28936, G29035, G29042, G30720, G28929, G29043, G29102, G28421, G29296, G29299, G29843, G31188, G29832, G29838, G29844, G29840, G29983, G30300, G30027, G29980, G30210, G30213, G30034, G30208, G30309, G30310, G30530, G30533, G30558, G30565, G32986, G30606, G30611, G30961, G30718, G30662, G30717, G31397, G31326, G31186, G31190, G31323, G29842, G34393, G31404, G31512, G31522, G31518, G31515, G31517, G30073, G32359, G32363, G32305, G32364, G32366, G32385, G32425, G32389, G32501, G32680, G32682, G32809, G32814, G34285, G32905, G32820, G32821, G32824, G32904, G32908, G33335, G33339, G33338, G33428, G33433, G34150, G34288, G34151, G34159, G34290, G34348, G34347, G34350, G34397, G34501, G34684, G34502, G34505, G34689, G30974, G34691, G34980, G34983, G34726

Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 20, 2011. 

Manufacturer: Elekta Oncology Systems (Fmrl Philipp’s), Crawley, West Sussex,   
UK. Firm initiated recall is ongoing.

A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board.

123 units

Nationwide, PR

1) Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. The recalled GEMINI TF 16 system units are identified as follows: Model Number: 882470 and Model #882473. Recall # Z-0343-2012;

 

2) Philips GEMINI TF 64 Diagnostic CT X-ray/PET Imaging System, Catalog/Model #882471, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. Recall # Z-0344-2012

1) Serial Numbers: 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7244, and 7237;

2) Serial Numbers: 7229, 7231, 7232, 7234, 7236, 7238, 7241, 7243, 7245, and 7246

Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated October 28, 2011. Firm initiated recall is ongoing.

In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers, the firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of these PET/CT system units.

19 units

Nationwide

Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag. Recall # Z-0508-2012

Lot numbers: 549490, 563542, 563543, 564885, 564886, 570133, 571504, 573502, 581088, 581439, and 582520.

Recalling Firm: DePuy Orthopedics, Inc., Warsaw, IN, by letters on November 9, 2011.

Manufacturer: Symmetry Medical New Bedford Inc., New Bedford, MA. Firm initiated recall is ongoing.  

DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt.

890 units

Nationwide

 

SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data. Recall # Z-0444-2012

SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32.

SCC Soft Computer, Clearwater, FL, by letter on July 26, 2011. Firm initiated recall is ongoing.

A test performed on the Roche Cobas Integra series of instruments when used with the GenInst/Dispatch listening program could cause incorrect flagging for a test result posted to the lab database.

265 units

Nationwide and Canada