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FDA MedWatch

LifePak CR Plus Automated External Defibrillators- Class I Recall Because The Shock Button Is Not Visible Which Impedes Responder's Ability To Provide Shock Therapy

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.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Recall Notice regarding this issue:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#LifePakCR

 

 
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