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Welch Allyn AED Defibrillators Recalled


The Food and Drug Administration (FDA) has announced Class 1 recalls of select AED 10 Defibrillators. This recall is further to a worldwide recall of 14,054 AED 10, and MRL JumpStart external defibrillators issued by Welch Allyn on March 11, 2009.

According to the company press release, "There is a remote chance that these devices may experience low energy shock, unexpected device shutdown, and/or susceptibility to electromagnetic noise interference. If such issues arise, it may prevent defibrillation of a patient in cardiac arrest and could lead to death. There have been 20 reported instances of low energy shock, 8 of electromagnetic noise interference, and 11 of unexpected device shutdown."

The defibrillators are used by emergency or medical personnel, or by others who have completed CPR AED training courses. They are intended to treat adults experiencing a heart attack (cardiac arrest). The device analyzes an unconscious patient's heart rhythm and automatically delivers an electrical shock to the heart if needed to restore a normal heart rhythm.

The defibrillators subject to recall were manufactured between October 3, 2002 and January 25, 2007.

MARCH-16-09: Three Class 1 Recalls: Welch Allyn AED 10 Automatic External Defibrillator (AED) and MRL JumpStart AED [FDA: WELCH ALLYN DEFIBRILLATORS RECALLED]

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Published on Mar-16-09


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