Physio Control Inc, are issuing a Class I recall of its LifePak CR plus automated external defibrillators (AED).
The LifePak CR plus AED uses voice prompts to instruct the responder to provide shock therapy by pressing the product’s shock button. However, a cover obscures the recalled version’s shock button, rendering the responder unable to provide shock therapy, prompting the recall.
The device was manufactured from May 20, 2004 through August 11, 2007 and distributed from May 20, 2004 through December 4, 2007.
The AED device should be removed from service or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover.
The manufacturer’s recall notice is available on the FDA Web site. Physio Control may be contacted at (425) 867-4000.