FDA Announces Class 1 Recall of AEDs

Chrissie Cole

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Physio Control Inc., issued a Class 1 recall of LifePack CR Plus Automated External Defibrillators (AED), used to treat adult patients in cardiopulmonary arrest.

The device works by instructing the responder, via voice prompts, to press the shock button. However, the button is covered and not clearly visible and therefore the responder is unable to receive shock therapy when needed.

The FDA recommends the AED device removal from service, or the manufacturer-provided diagram can be help assist the patient to remove and discard the shock button cover.

249 devices manufactured from May 20, 2004 through August 11, 2997 have been affected by the recall.

Customers with questions may visit the following website for more information or to enter the serial numbers of their devices to determine if they have a recalled device that is affected by the recall. Customers may also call Physio-Control Technical Support at 1-800-442-1142, option 5, between 6:00 a.m. and 4:00 p.m. (Pacific Time).