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Welch Allyn Issues Voluntary Worldwide Recall of Select AED10 Automatic External Defibrillators

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Welch Allyn has issued a voluntary worldwide recall of 1,794 AED10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007. 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.

It has been reported that these group of devices may experience failure or unacceptable delay in analyzing the patient's ECG and may not deliver appropriate therapy, which could possibly result in failure to resuscitate the patient.  While no adverse affects have occurred as a result of this error, Welch Allyn is taking preventative corrective action to update this select group of devices.

The company has observed 49 failures in the manufacture of the AED10 defibrillators, and has received 3 customer complaints which the company deems an unacceptable risk. The failures were traced to defective capacitors manufactured by a vendor at one factory and used on two lots of printed circuit board assemblies.  The failure observed in the AED10 defibrillator depends upon the location of the defective capacitor on the circuit board.  The malfunctions at the device level include a flashing status indicator, excessive battery drain resulting in shortened battery life, continuous device resets rendering the device non-operational, and no shock advised with a ventricular fibrillation input.

This recall comes just after two months after Welch Allyn recalled the AED20 Defibrillator for similar reasons. The product was recalled to correct a condition that could result in a malfunction that prevents or unacceptably delays the delivery of a defibrillating shock. 21 complaints were received about this device and 1696 devices were recalled.

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