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U.S. Department of Health and Human Services

Safety

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Defibtech Lifeline and ReviveR Automated External Defibrillators

Audience: Emergency services personnel, risk managers, consumers

[Posted 03/07/2007] Defibtech and FDA notified healthcare professionals of a worldwide recall of 42,000 Lifeline and ReviveR AEDs with software versions 2.002 and earlier. The self-test software may allow a self-test to clear a detected low battery condition. The operator may be unaware of the low battery and the device may not deliver a defibrillation shock, resulting in failure to resuscitate a patient. The company provided a maintenance procedure that can be used to verify functionality of the device until the software upgrade has been installed, allowing the device to remain in service. The devices were distributed to schools, fire & EMS, businesses, health clubs and hospitality companies.

[March 07, 2007 - Recall Notice - FDA]
[March 06, 2007 - Firm Press Release - Defibtech]