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U.S. Department of Health and Human Services

Safety

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HeartSine Technologies, Inc. Samaritan Automatic External Defibrillators (AED)

Audience: Emergency healthcare professionals and Cardiologists

FDA and HeartSine Technologies, Inc. notified healthcare professionals of a worldwide recall of 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. 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. Distributors and customers should contact the manufacturer to determine if their product(s) are affected, and arrange to obtain a field upgrade kit as soon as possible.

[March 22, 2005 - Recall Notice - FDA]
[March 18, 2005 - Press Release - FDA]