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www.fdanews.com/articles/71510-additional-medtronic-lifepak-aeds-affected-in-recall

Additional Medtronic LifePak AEDs Affected in Recall

April 25, 2005

Medtronic has identified an additional 396 monophasic LifePak 500 automated external defibrillators (AEDs) to be included in a voluntary Class I recall originally announced Feb. 25.

The affected AEDs may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. Failure to analyze the patient's heart rhythm will inhibit defibrillation, if it is needed. The company said it will be contacting the owners of the additional 396 devices that are in use worldwide.

Medtronic has already completed the updates or upgrades to the devices originally identified as affected. The company plans to complete the update or upgrade to the additional affected devices by May 31. Affected AEDs may remain in service, and customers with devices in this additional group are currently being contacted with recommendations for use and replacement schedules. Only certain monophasic LIFEPAK 500 AEDs manufactured in 1997 are included in this action.