(Note: Click here for the AED Recall from March 11, 2009)
The recall affects all Lifeline and Revive R automated external defibrillators with software versions 2.002 and earlier. The self-test software for these defibrillators may allow a self-test to clear a previously detected low battery condition. If this situation occurs, the operator may be unaware of the low battery, and the defibrillator may be unable to deliver a defibrillation shock, which could result in failure to resuscitate a patient.
Defibtech recalled the device after learning of three reports of malfunctions from owners of these heart defibrillators. The company has provided a maintenance procedure that can be used to verify functionality of the device until the software upgrade has been installed, allowing the device to remain in service. A copy of this maintenance procedure is being mailed to customers.
The maintenance procedure and instructions on determining the software version of a unit can be found on the www.defibtech.com/fa2007 web page. For questions regarding this external heart defibrillator recall, please refer to the above referenced web page, contact your distributor or contact Defibtech at [email protected], 1-877-453-4507 or 1-203-453-4507.
Defibtech will provide customers with a free software upgrade to address this issue for all affected The software upgrade is expected to be available within the next 10 weeks.
Defibtech has distributed approximately 42,000 units worldwide through distributors to end users including: schools, fire & EMS, businesses, health clubs and hospitality companies. The products can be identified by the words “Lifeline AED®” and “ReviveR AEDTM” on the front of the device.
The Food and Drug Administration (FDA) has determined that this action is a Class I recall. Class I recalls are the most serious type of recall and involve 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.