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News

Physio-Control recalls LIFEPAK CR Plus automated external defibrillators

Medtronic : 15 September, 2008  (Company News)
Physio-Control, a wholly-owned subsidiary of Medtronic, has announced that the FDA has classified as a Class I action the company’s recently initiated and completed voluntary urgent medical device recall of 249 fully automatic LIFEPAK CR Plus automated external defibrillators (AEDs).
Certain fully automated devices manufactured from May 2004 through April 2007 are mis-configured with the software intended for semi-automatic AEDs. With this configuration set up, if the responder is instructed to press the shock button to deliver therapy, they will not be able to locate the shock button because it is covered in the fully automated device. In this situation, it is possible that therapy could be delayed or not delivered at all; possibly resulting in death. There has been one patient related complaint associated with this issue.

As of September 2, 2008, the company has notified all affected customers and shipped replacement devices at no charge. During the brief interval while customers awaited receipt of replacement devices, Physio-Control recommended that customers with the identified, affected defibrillators either remove the affected AED(s) from service or remove and discard the shock button cover (instructions provided).

If customers have questions or would like additional information they should contact Physio-Control Technical Support. Customers may also visit the company’s website at 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.
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