Date Issued |
Title |
Text |
PDF |
7/14/2008 |
Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning |
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7/1/2008 |
Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion |
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3/17/2008 |
Updated Data on Mortality Associated with the Medtronic AneuRx® Stent Graft System |
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2/25/2008 |
Denture Cleanser Allergic Reactions and Misuse
See Related Document: Advice to Patients |
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1/15/2008 |
Unretrieved Device Fragments |
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12/12/2007 |
Patient Burns from Electric Dental Handpieces |
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12/11/2007 |
Deaths reported following Radio Frequency Ablation of Lung Tumors |
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12/4/2007 |
Vail Products Enclosed Bed Systems |
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10/31/2007 |
Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment
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10/10/2007 |
Importance of Vaccination in Cochlear Implant Recipients
See Related Document: Advice to Patients |
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8/13/2007 |
Repair, Service, or Testing May Not Have Been Performed on Certain Baxter COLLEAGUE and FLO-GARD Infusion Pumps
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7/12/2007 |
Advice for Patients: Possible Burns or Fires from Heating Pads Manufactured by HoMedics, Inc.
See Related Document: Questions and Answers on HoMedics®, Inc. Heating Pads and General Heating Pad Safety (7/24/2007)
See Related Document: Public Health Advisory: Hazards Associated With The Use of Electric Heating Pads
(NOTE: Although this Advisory was released in 1995, the recommendations are still valid.) |
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5/31/2007 |
Acanthamoeba Keratitis Infections Potentially Related to Complete MoisturePlus Multipurpose Contact Lens Solution Manufactured by Advanced Medical Optics (AMO)
See Related Document: Advice to Patients |
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|
5/18/2007 |
Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Devices Manufactured by Shelhigh, Inc.
See Related Document: Advice to Patients |
|
|
3/1/2007 |
Unpredictable Events in Medical Equipment due to New Daylight Saving Time Change
See Related Document: Advice to Patients |
|
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2/27/2007
Updated
7/16/2007 |
Updated Information on Custom Ultrasonics, Inc., Endoscope Washer/Disinfector |
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2/1/2007 |
Precautions in Using the Reintroduced Vapotherm® 2000i [Respiratory Gas Humidifier] System |
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6/19/2006
Updated 6/22/2006 |
Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures |
|
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4/24/2006
Updated 6/19/2006 |
Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals |
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4/10/2006
Updated 5/31/2006 |
Fungal Keratitis Infections Related to Contact Lens Use
See Related Document: Advice to Patients |
|
|
2/27/2006 |
Update: Gambro Prisma® Continuous Renal Replacement
System |
|
|
2/06/2006 |
Continued Risk of Bacterial Meningitis in Children
with Cochlear Implants with a Positioner Beyond Twenty-Four Months
Post-Implantation
See Related Document: Advice
to Patients |
|
|
12/28/2005 |
Second Update: Guidant VENTAK PRIZM® 2 DR and
CONTAK RENEWAL® Implantable Cardioverter Defibrillators
See
Related Document: Advice to Patients |
|
|
11/16/2005 |
Risk of Electromagnetic Interference with Medical Telemetry
Systems Operating in the 460-470 MHz Frequency Bands |
|
|
10/13/2005
(See 12/28/05 Update) |
Update: Guidant VENTAK PRIZM® 2 DR and CONTAK
RENEWAL® Implantable Cardioverter Defibrillators
See
Related Document: Advice to Patients |
|
|
7/29/2005 |
Complications from Metallic Tracheal Stents in Patients
with Benign Airway Disorders |
|
|
7/14/2005
(See 12/28/05 Update) |
Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL®
Implantable Cardioverter Defibrillators
See
Related Document: Advice to Patients |
|
|
11/25/2003
Updated 10/18/2004 |
Final Update of Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent |
|
|
3/25/2005
Updated 6/24/2005 |
Vail Products Enclosed Bed Systems |
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|
5/10/2005 |
MRI-Caused Injuries in Patients with Implanted Neurological
Stimulators |
|
|
10/31/2002
Updated 5/7/2004
|
Complications Related to the Use of Bone Cement and Bone Void Fillers in Treating Compression Fractures of the Spine |
|
|
12/19/2003
Updated 5/7/2004 |
Counterfeit Polypropylene Mesh |
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|
4/2/2004 |
Paralysis from Absorbable Hemostatic Agent |
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|
12/18/2003 Updated 3/30/2004 |
Safety Tips for Preventing Hospital Bed Fires |
|
|
12/17/2003 |
Updated Data on Mortality Associated with Medtronic
AVE AneuRx® Stent Graft System
|
|
|
12/19/2002 |
Diathermy Interactions with Implanted Leads and Implanted
Systems with Leads
|
|
|
10/23/2002 |
Non-Corrective Decorative Contact Lenses Dispensed
Without a Prescription |
|
|
7/12/2002 |
PVC Devices Containing the Plasticizer DEHP |
|
|
11/2/2001 |
Reducing Radiation Risk from Computed Tomography for
Pediatric and Small Adult Patients |
|
|
7/20/2001 |
Potential for Injury from Medical Gas Misconnections
of Cryogenic Vessels |
|
|
4/27/2001 |
Problems with Endovascular Grafts for Treatment of
Abdominal Aortic Aneurysm (AAA) |
|
|
3/13/2001 |
Lead Exposure from Dental Films Stored in Lead-Lined
Table-top Containers |
|
|
10/11/2000 |
Serious Injuries from Microwave Thermotherapy for Benign
Prostatic Hyperplasia |
|
|
8/29/2000 |
Potential for Injury from Circumcision Clamps |
|
|
7/10/2000 |
Risk of Electromagnetic Interference with Medical Telemetry
Systems |
|
|
10/8/1999 |
Complications Related to the Use of Vascular Hemostasis
Devices |
|
|
9/10/99 |
Infections from Endoscopes Inadequately Reprocessed
by an Automated Endoscope Reprocessing System |
|
|
5/11/99 |
Potential Cross-Contamination Linked to Hemodialysis
Treatment |
|
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5/4/99 |
Hypotension and Bedside Leukocyte Reduction Filters |
|
|
2/22/99 |
Glass Capillary Tubes: Joint Safety Advisory About
Potential Risks |
|
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2/4/99 |
Explosions and Fires in Aluminum Oxygen Regulators |
|
|
10/8/98 |
NIR ON Ranger w/SOX Premounted Stent System |
|
|
9/28/98 |
Important Information on Anti-Theft and Metal Detector
Systems and Pacemakers, ICDs, and Spinal Cord Stimulators |
|
|
9/25/98 |
Illegal Promotion of Contact Lenses |
|
|
8/3/98 |
Electrical Hazards Associated With Lead Wires and Cables |
|
|
5/21/98 |
Need for CAUTION When Using Vacuum Assisted Delivery
Devices |
|
|
4/13/98 |
Warning Regarding the Use of the AbTox Plazlyte™
Sterilization System |
|
|
3/20/98 |
Interference Between Digital TV Transmissions and Medical
Telemetry Systems |
|
|
3/13/98 |
Potential Hypersensitivity Reactions To Chlorhexidine-Impregnated
Medical Devices |
|
|
3/12/98 |
Supplemental Information Regarding: Failure of Isocam
II, Dual-Headed Nuclear Medicine Gamma Camera |
|
|
2/13/98 |
Failure of Isocam II, Dual-Headed Nuclear Medicine
Gamma Camera |
|
|
8/13/97 |
Vacuum Loss in Electronic Resonating Components |
|
|
7/25/97 |
Limitations of Toxoplasma IgM Commercial Test Kits |
|
|
7/7/97 |
Assays for Antibodies to Borrelia burgdorferi; Limitations,
Use, and Interpretation for Supporting a Clinical Diagnosis of Lyme
Disease |
|
|
5/21/97 |
Steam Re-Sterilization Causes Deterioration of Zirconia
Ceramic Heads of Total Hip Prostheses |
|
|
4/17/97 |
Potential Infection Problem With Medical Devices Rented
or Leased by Health Care Facilities |
|
|
3/24/97 |
Risks of Devices for Direct Detection of Group B Streptococcal
Antigen |
|
|
12/16/96 |
Important Information Relating to Cellulose Acetate
Dialyzers |
|
|
10/10/96 |
Dear Manufacturers and Users of Lasers for Refractive
Surgery |
|
|
6/27/96 |
Potential Risk of Spontaneous Combustion in Large Quantities
of Patient-Examination Gloves |
|
|
12/12/95 |
Hazards Associated With The Use of Electric Heating
Pads |
|
|
10/16/95 |
Retinal Photic Injuries From Operating Microscopes
During Cataract Surgery |
|
|
8/23/95 |
Entrapment Hazards With Hospital-Bed Side Rails |
|
|
7/15/94 |
Important Information About TMJ Implants |
|
|
9/30/94 |
Avoidance of Serious X-Ray-Induced Skin Injuries to
Patients During Fluoroscopically Guided Procedures |
|
|
4/18/94 |
Hazards of Precipitation Associated With Parenteral
Nutrition |
|
|
3/1/94 |
Avoiding Injuries From Rapid Drug or I.V. Fluid Administration
Associated With I.V. Pumps And Rate-Controller Devices |
|
|
2/28/94 |
Occluded Endotracheal Tubes |
|
|
12/28/93 |
Unsafe Electrode Lead Wires and Patient Cables Used
With Medical Devices |
|
|
9/15/93 |
Hazards of Volume Ventilators and Heated Humidifiers |
|
|
9/3/93 |
Unsafe Patient Lead Wires and Cables |
|
|
8/19/93* |
Fluoride Contamination of Hemodialysis Water Supply |
|
|
7/14/93 |
Hazards of Heated-Wire Breathing Circuits |
|
|
11/25/92 |
MRI-Related Death of Patient With Aneurysm Clip |
|
|
10/23/92 |
Important Information About New Studies on Dialyzer Germicides |
|
|
7/15/92 |
Potential Hazards With Restraint Devices |
|
|
5/29/92 |
Caude Equina Syndrome - Use of Catheters |
|
|
5/20/92 |
Aluminum and Other Trace-Element Contamination in Dialysis Facilities |
|
|
4/21/92 |
Important Information on Shiley CC Valve Fractures |
|
|
4/16/92 |
Needlestick and Other Risks From Hypodermic Needles on Secondary I.V. Administration Sets - Piggyback and Intermittent I.V. |
|
|
3/6/92 |
Anaphylactoid Reactions Associated With ACE Inhibitors and Dialyzer Membranes |
|
|
9/91 |
Vitek Proplast Temporomandibular Joint Implants |
|
|
12/28/90 |
Serious Problems With Proplast-Coated TMJ Implant |
|
|
8/28/90 |
Hepatitis B Transmission Via Spring-Loaded Lancet Devices |
|
|
5/11/90 |
Gas/Air Embolism Associated With Intrauterine Laser Surgery |
|
|
2/16/90 |
Important Tips for Apnea Monitor Users |
|
|
5/30/89 |
New FDA Recommendations & Results of Contact Lens Study |
|
|
3/15/89 |
Sodium Azide Contamination of Hemodialysis Water Supplies |
|
|
1/24/89 |
Homemade Saline Solutions for Lenses |
|
|
2/19/88 |
Chloramine Contamination of Hemodialysis Water Supplies |
|
|
4/28/87 |
Possibly Contaminated Dura Mater |
|
|
6/19/85 |
Apnea Monitors |
|
|
3/28/85 |
Defibrillator Batteries |
|
|
11/30/83 |
Dialyzer: First-Use Syndrome |
|
|
9/2/83 |
Breathing System Connectors |
|
|
6/16/83 |
Electrically Powered Hospital Beds |
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|