15/11/2007

Welch Allyn GmbH & Co. KG

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

Welch Allyn today announced it is initiating a voluntary worldwide recall of 1,794 AED10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007 at the Welch Allyn Protocol, Inc. facility in Beaverton, OR. This select 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.

No other devices besides those manufactured between the above dates are subject to this recall. Welch Allyn initiated notification via certified mail on October 24 to its customers who purchased AED10 defibrillators in this group of devices-1175 of which were sold within the US and 619 outside the US. Owners of these defibrillators should contact Welch Allyn at 1-800-462-0777 option 4 to arrange for an exchange unit.

This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration (FDA). Customers with questions may contact Welch Allyn Technical Support at 1-800-462-0777 for more information. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.