Date Recall Initiated |
October 26, 2007 |
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Product: |
Welch Allyn AED 10™ Automatic External Defibrillators, manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970309E, 970310E, and 970311E |
Use: |
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. |
Recalling Firm: |
Welch Allyn Protocol, Inc. 8500 Sw Creekside Pl Beaverton, OR 97008 |
Reason for Recall: |
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. |
Public Contact: |
Customers may call Welch Allyn’s Technical Support at 1-800-462-0777. |
FDA District: |
Seattle |
FDA Comments: |
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.
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Updated November 28, 2007
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