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U.S. Department of Health and Human Services

Safety

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Welch Allyn AED 10 Automatic External Defibrillators

Audience: Emergency services personnel, risk managers, and consumers

[UPDATE 11/28/2007] Recall expanded to include Welch Allyn AED 10™ Automatic External Defibrillators, manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970309E, 970310E, and 970311E.

[Posted 11/05/2007] FDA issued a Class I recall for Welch Allyn AED 10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970310E, and 970311E. These devices are used by emergency or medical personnel, or by others who have taken the appropriate training in cardiopulmonary arrest (heart attack). They analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.

There is a possibility that these recalled devices may experience failure or unacceptable delay in analyzing a patient’s ECG resulting in possible failure to deliver the appropriate therapy. The possible failure or delay depends on the location of the defective part that stores an electrical charge on the circuit board. The company plans to replace all affected units and has set up a call center for customers.

[November 02, 2007 - Recall Notice - FDA]