About two months ago, Welch Allen recalled some 1,700 Automatic External Defibrillators (AEDs). Recently, that recall has been extended to another 1,700 units in a different model line.
The product recalled is the Welch Allyn AED 10™ Automatic External Defibrillators, manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970310E, and 970311E. 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.
Customers may call Welch Allyn’s Technical Support at 1-800-462-0777. Welch Allyn issued a press release on October 30, 2007, has set up a call center for customers, and plans to send three certified mailings to notify affected customers. The first letter, dated October 26, 2007, was sent via certified mail which informed customers which serial numbers were affected, and where the serial number is located (at the upper left hand corner of the back panel of the device). The letter includes a response form and the firm’s contact information. Owners of the device should contact Welch Allyn at 1-800-462-0777 (option 4) to arrange for a replacement that will include a new five year warranty. The company plans to replace all affected units before recovering all the devices.
For more information about this recall, please see the company’s press release at: http://www.welchallyn.com/pressroom/releases/2007/2007-10-30%20-%20AED%2010%20Recall.htm
More info: http://www.fda.gov/cdrh/recalls/recall-102607.html
