Recall of Welch Allyn Defibrillators

November 2007

UPDATE – Welch Allyn has modified their AED 10 Automatic External Defibrillator recall to include a wider range of part numbers. The recalled defibrillators still include models made from March 29, 2007 to August 9, 2007. The following AED 10 part numbers are included in the recall:

• 970302E
• 970308E
• 970309E
• 970310E
• 970311E

Attention healthcare professionals and heart patients – Welch Allyn has recalled select models of their AED10 Automatic External Defibrillators. The defective Welch Allyn AED10 defibrillators could experience failure or delay patient EKG results, resulting in the failure to resuscitate patients.

Welch Allyn has observed 49 instances of product failure, along with three consumer reports of defective AED10 models. Malfunctions include excessive battery drainage, flashing status indicator lights, uncontrolled device resets, and failure to provide life-saving shocks.

The recalled defibrillators were made in 2007, from March 29 – August 9. The recall has been announced by the Food and Drug Administration as a Class 1 recall, the most serious rating given by the government agency. A Class 1 recall indicates that a faulty product could lead to serious injury or even death.