September 12, 2008 - Physio-Control Inc., a wholly-owned subsidiary of Medtronic, said today it completed a voluntary, urgent medical device recall of 249 fully automatic LIFEPAK CR Plus automated external defibrillators (AEDs) because they are mis-configured with the software intended for semi-automatic AEDs.
The FDA classified the recall as a Class I action. 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 FDA said 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 company said there has been one patient related complaint associated with this issue.
The recall is for fully automated devices manufactured from May 2004 through April 2007. As of Sept. 2 the company has notified all affected customers and shipped replacement devices at no charge.
The LIFEPAK CR Plus automated external defibrillators (AEDs) are battery operated and portable. These AEDs are placed in public access environments such as schools, airports, city halls, retail locations and workplaces. Anyone with minimal CPR/AED training can use an AED to provide a defibrillation shock to someone in sudden cardiac arrest.
For more information: www.physio-control-notices.com/config, www.fda.gov/cdrh/recalls/recall-082808.html