Welch Allyn Recalls Some AED 10 AEDs

Welch Allyn Protocol, Inc. of Beaverton, Ore., has recalled AED 10(TM) Automatic External Defibrillators manufactured between March 29, 2007 and Aug. 9, 2007, with part numbers 970302E, 970308E, 970310E, and 970311. This is classified as a Class 1 Recall by FDA, which posted a notice of it on the MedWatch Web site.

The notice said the recalled devices "may experience failure or unacceptable delay in analyzing a patient's ECG resulting in possible failure to deliver the appropriate therapy." Welch Allyn's Oct. 30 press release said it has observed 49 failures in the manufacture and has received three customer complaints; the company said a defective capacitor made by a vendor at one factory and used on two lots of printed circuit board assemblies is the faulty part. The failures depends on the capacitor's location on the circuit board -- it has shown up as a flashing status indicator, excessive battery drain, continuous device resets, and no shock advised with a ventricular fibrillation input, Welch Allyn said.

Customers may call Welch Allyn's Technical Support, 800-462-0777, to arrange for a replacement AED that will include a new five-year warranty. The company has set up a call center for customers and will send three certified mailings to notify affected customers.

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