ROCKVILLE, Md. -- More than 40,000 automatic external defibrillators in schools, health clubs, and other public sites have been recalled because of a potentially faulty low-battery signal, the FDA reported.
ROCKVILLE, Md., March 8 -- More than 40,000 automatic external defibrillators in schools, health clubs, and other public sites have been recalled because of a potentially faulty low-battery signal, the FDA reported.
The voluntary worldwide recall was initiated last month by Defibtech, of Guilford, Conn., when the company discovered a flaw in the device's self-test software. As a result the test program failed to detect a low-battery condition in the units, which could prevent the device from delivering a shock on demand.
The words "Lifeline AED" and "ReviveR AED" appear on the front of the 42,000 recalled devices, said the FDA. The recall notice included all Lifeline and ReviveR defibrillators with software versions 2.002 and earlier. In addition to schools and health clubs, the defibrillators were marketed to hotels, fire departments, and emergency services departments.
The FDA said the recall was the most serious type of recall involving situations "in which there is a reasonable probability that, should this particular malfunction occur, use of the affected product may cause serious injury or death if the problem is not corrected."
Defibtech sent out a recall notice to distributors and customers on Feb. 22 after it received three reports of malfunctions involving the self-test feature of the defibrillators.
The FDA said the company has provided a maintenance procedure that can be used to verify functionality of the device until a software upgrade has been installed, allowing those devices with functioning self-tests to remain in service. A copy of this maintenance procedure is being mailed to customers.
The maintenance procedure, as well as instructions for determining the software version of a unit, is on the www.defibtech.com/fa2007 web page.
The FDA said that the Defibtech has also agreed to provide customers with a free software upgrade for all affected defibrillators. This software upgrade, which can be installed in the field where the unit is located, is expected to be available within the next 10 weeks.