HeartSine Issues Worldwide Recall of Certain AEDs

HeartSine Technologies is initiating a worldwide recall of some samaritan automatic external defibrillators (AEDs) -- specifically, models SAM-001, SAM-002 and SAM-003 with certain serial numbers within the range of 1270-2324 -- because they may shut down before delivering a shock, which could result in the delayed 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. 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 and seventy-two of the HeartSine samaritan AEDs in question were distributed, with 532 in the U.S. and U.S. territories. The products can be identified by the words "samaritan AED" on the front of the device. The HeartSine samaritan PAD AED (Model SAM-300) is not subject to this action. The FDA has determined that this action is a Class I recall.