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FDA > CDRH > Medical Device Recalls > Class I Recall - HeartSine Technologies, Inc. Automatic External Defibrillators

Medical Device Recalls
Class I Recall: HeartSine Technologies, Inc. Automatic External Defibrillators

Date Recall
Initiated
 February 14, 2005
Product:
 Samaritan® Automatic External Defibrillator (AED), models SAM-001, SAM-002, and SAM-003 with certain serial numbers within the range of 1270 - 2324. Six hundred seventy-two (672) of the affected AEDs were distributed, with five hundred thirty-two (532) within the U.S. and U.S. territories. The products can be identified by the words “samaritan® AED” on the front of the device.
Use:
 Automatic external defibrillators are intended to be used for the treatment of cardiac arrest. The defibrillators are intended to deliver a shock to the heart to restore normal heart rhythm. Prior to delivering the shock, the device analyzes the patient’s heart rhythm to determine if a shock is appropriate.
Recalling Firm:
 HeartSine Technologies, Inc.
940 Calle Amanecer Ste E
San Clemente, CA 92673-6218
Reason for Recall:
 The affected AEDs may in some cases shut down before delivering a shock, which could result in a delay in treatment or death of a viable patient. This recall was initiated after receipt of several user complaints of shut-down during an attempted charge. HeartSine believes that some of the devices could exhibit longer than usual charging rates, causing an alarm and shutdown of the device.
Public Contact:
 Consumers with questions may contact the company at 1-949-218-0092 or 1-866-478-7463.
FDA District:
 Los Angeles
FDA Comment:

HeartSine Technologies, Inc. initiated notification of its distributors and customers by letter on February 14, 2005, and is providing a user-installable field software upgrade for all affected AEDs. Distributors and customers who have HeartSine samaritan® AEDs within this serial number range, who have not yet received an upgrade kit, should contact the manufacturer to determine if their product(s) are affected, and if so, arrange to obtain a field upgrade kit as soon as possible.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

 

For additional information on this product recall, see the FDA press releases at http://www.fda.gov/oc/po/firmrecalls/heartsine03_05.html.

Updated March 22, 2005

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