FDA, Welch Allyn initiate Class 1 recall of more than 14K defibrillators

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Welch Allyn AED 10 Defibrillator. Image Source: Welch Allyn

The FDA and Welch Allyn have notified healthcare professionals and consumers of a nationwide Class I recall of 14,054 automatic external defibrillator (AED) 10 and MRL JumpStart AEDs manufactured between Oct. 3, 2002 and Jan. 25, 2007.

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, according to the FDA.

The devices may experience low energy shock, unexpected device shutdown and/or susceptibility to electromagnetic noise interference which may prevent defibrillation during cardiac arrest and could lead to death, according to the Skaneateles Falls, N.Y.-based company.

This devices are used by emergency or medical personnel, or by others who have completed CPR AED training courses, in treating adults� experiencing a heart attack.