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www.fdanews.com/articles/62296-medtronic-to-correct-faulty-defibrillators

MEDTRONIC TO CORRECT FAULTY DEFIBRILLATORS

September 6, 2006

Medtronic is voluntarily correcting certain defibrillator/monitors that may shut down without warning when operating on backup (DC) battery power, the firm said this week. The LIFEPAK 20 defibrillator/monitors were distributed between December 2005 and March 2006 and have version 38 software.

When the device shuts down, all defibrillator functions, including therapy delivery, stop until the defibrillator is reconnected to AC power. The issue was identified during verification testing at Medtronic ERS, the company said, adding that it has not received customer reports related to this issue.