The Food and Drug Administration (FDA) has recalled several of Welch Allyn’s Protocol automatic external defibrillators (AEDs) because they may fail or unacceptably delay in analyzing a patient’s heart rhythm, resulting in a failure to restore normal heart rhythm via electrical shock.
The AED parts carry the numbers 970302E, 970308E, 970310E, and 970311E, and were manufactured between March 29, 2007, and August 9, 2007.
This is a Class 1 recall, the most serious type, and indicates a reasonable probability of injury or death with product use. The FDA is urging health care providers to stop using the defibrillators, and call 800-462-0777 for a replacement. For more information, visit www.fda.gov/medwatch/safety/2007/safety07.htm#aed10
