Unsafe Drugs: Defibtech Recalls Defibrillators Worldwide

Defibtech, LLC, has begun a worldwide voluntary recall of the Lifeline AED and ReviveR AEDTM external defibrillators. The recall affects all machines with software versions 2.002 and earlier because the self-test options on these devices may cause a previously detected low battery condition to become cleared. In cases of low battery, the defibrillator may be unable to deliver a shock in order to resuscitate a patient.

Defibtech Recalls Lifeline and ReviveR Automated External Defibrillators Worldwide

Defibtech notified affected distributors and customers by letter on February 22, 2007. The need for the recall was determined after three reports of malfunctions from end users. A maintenance program has been devised by the company that should establish whether the unit is functional until Defibtech is able to create a software upgrade to solve the problem. The Food and Drug Administration has determined that this is a Class I recall; Class I recalls are the most serious kind of recall and are declared in cases where malfunction can result in serious injury or death.