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Heartsine Technologies, Inc. Issues Worldwide Recall of Certain Automatic External Defibrillators

Mar 18, 2005 | www.fda.gov

HeartSine Technologies, Inc., San Clemente, California, is initiating a worldwide recall of some samaritan® Automatic External Defibrillators (AEDs). This recall affects HeartSine samaritan® AED models SAM-001, SAM-002, and SAM-003 with certain serial numbers within the range of 1270 - 2324. These devices 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 Technologies, Inc. believes that some of the affected devices could exhibit longer than usual charging rates, causing an alarm and shutdown of the device as mentioned above. No injuries have been reported to date.

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.

Six hundred seventy-two (672) of the affected HeartSine samaritan® AEDs were distributed, with five hundred thirty-two (532) within U.S. and U.S. Territories. The products can be identified by the words "samaritan® AED" on the front of the device. Please note that the HeartSine samaritan® PAD automatic external defibrillator (Model SAM-300) is NOT subject to this action.

This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration (FDA). FDA has determined that this action is a Class I recall. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the affected product may cause serious injury or death if the problem is not corrected.


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