Welch Allyn Automated External Defibrillators (AED) Recalled

The device company Welch Allyn is recalling about 14,000 automated external defibrillators. The affected models are AED 10 and MRL JumpStart defibrillators manufactured between October 3, 2002 and January 25, 2007.

A number of problems have been reported with these defibrillators. They include devices that deliver less defibrillation energy than they were programmed for, susceptibility to electromagnetic interference, and unexpected shutdown during use. These problems could prevent a patient in cardiac arrest from being defibrillated, which could be fatal.

The company has sent a letter to its customers about the recall, giving them instructions to return their units without delay so they may be repaired or replaced.

Customers in the U.S. and Canada may either exchange their AED 10 for a similar device at no cost, or purchase a new AED 10 directly from Welch Allyn at a reduced cost. International customers will be offered exchange AED 10 devices.

For more information, contact the company at 1-888-345-5356.

FDA Patient Safety News: May 2009

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=86#7

Category:

Education

Tags:

• Recall
• AED
• defibrillator
• FDA
• cardiac arrest
• heart attack
• Welch Allyn

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