Class 1 Recall: Welch Allyn AED 10™ Automatic External Defibrillators

October 26, 2007

Welch Allyn AED 10™ Automatic External Defibrillators, manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970309E, 970310E, and 970311E

These devices are used by emergency or medical personnel, or by others who have taken the appropriate training to use an AED10™ automatic external defibrillator. These devices are intended to treat adults 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.

• 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

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online:www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178