DEFIBTECH RECALLS 42,000 AEDS, CITING SOFTWARE GLITCH

Defibtech, a manufacturer of automatic external defibrillators (AEDs), has announced a worldwide voluntary recall of two models of AEDs due to a software problem. A total of 42,000 devices have been recalled.

"The self-test software for these devices may allow a self-test to clear a previously detected low battery condition," the firm said March 6. "If this situation occurs, the operator may be unaware of the low battery, and the device may be unable to deliver a defibrillation shock, which could result in failure to resuscitate a patient."

The FDA has determined that this action is a Class I recall, the most serious type of recall, the firm noted.

The recall affects all devices with software versions 2.002 and earlier, according to Defibtech. The firm alerted distributors and customers of the problem in a Feb. 22 letter that was sent after the firm received three reports of device malfunctions. The firm said it would provide a free software upgrade within the next 10 weeks.