Class I Recall: Welch Allyn AED 10 and and MRL JumpStart Defibrillators
MedSun: Newsletter #35, April 2009

FDA MedWatch Safety Alert

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.

Additional Information:

Class I Recall: Welch Allyn AED 10 and and MRL JumpStart Defibrillators. FDA MedWatch Safety Alert. March 16, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm127781.htm

Class I Recall: Welch Allyn AED 10 and and MRL JumpStart Defibrillators. FDA Recall. December 15, 2008.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm122797.htm


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