Physio Control Inc. Recalls LifePak CR Plus AEDs
Physio Control Inc. has issued a recall of the LifePak CR Plus Automated External Defibrillators (AED), which is 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.
The recall affects 249 devices that were manufactured from May 20, 2004 through Aug. 11, 2007 and distributed from May 20, 2004 through Dec. 4, 2007.
Physio Control began calling their customers on Aug. 28, 2008, and:
- described the problem of the covered and invisible shock button, and the inability to provide shock to adults who may be having a heart attack;
- informed their customers that their AEDs would be replaced immediately;
- sent a follow-up letter that was faxed or e-mailed the same day stating that the customers should immediately perform one either remove the affected AEDs from service or remove and discard the shock button cover (a diagram showing what to do was enclosed).
The company completed notifying its customers on Sept. 2, 2008.
Customers with questions may visit www.physio-control-notices.com/config for more information or to enter the serial numbers of their devices to determine if they are affected by this action. Customers may also call Physio-Control Technical Support at 1-800-442-1142, option 5, between 6 a.m.-4 p.m. PST.
Health care professionals and consumers may also report any problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm, or go to