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U.S. Department of Health and Human Services

Safety

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Welch Allyn AED 10 and and MRL JumpStart Defibrillators

Audience: Emergency services personnel, risk managers, and consumers

[Posted 03/16/2009] FDA and Welch Allen notified healthcare professionals and consumers of a nationwide Class I recall of 14,054 AED 10 and MRL JumpStart external defibrillators manufactured between October 3, 2002 and January 25, 2007. 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. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. See the Recall Notice for additional instructions and contact information.

[March 16, 2009 - Recall Notice - FDA]