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U.S. Department of Health and Human Services

Safety

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LifePak CR Plus Automated External Defibrillators

Audience: Emergency medical personnel, other healthcare professionals

[UPDATE 09/16/2008] Recall classified by FDA as Class I. See the Recall notice for product numbers affected by this recall.

[Posted 09/11/2008] Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in cardiopulmonary arrest. The product was recalled because the AED instructs the responder by voice prompts to press the shock button which is not visible because it is covered, thereby making the responder unable to provide shock therapy. The AED device should be removed from service, or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover.

[September 11, 2008 - Recall Notice – FDA]