Recall -- Firm Press Release
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Defibtech Announces a Worldwide Voluntary Recall of Lifeline and ReviveR Automated External Defibrillators
FOR IMMEDIATE RELEASE -- Guilford, CT -- March 6, 2007 – Defibtech, LLC, is initiating a voluntary worldwide recall of the Lifeline AED® and ReviveR AEDTM (semi-automatic external defibrillators). This recall affects all Lifeline and ReviveR AEDs with software versions 2.002 and earlier. The self-test software for these devices 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 device may be unable to deliver a defibrillation shock, which could result in failure to resuscitate a patient.
Defibtech initiated notification of its distributors and customers by letter on February 22, 2007. Defibtech determined the need for this recall after learning of three reports of malfunctions from end users. 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. This procedure, as well as instructions on determining the software version of a unit, can be found on the www.defibtech.com/fa2007 web page. For questions regarding this recall, please refer to the above referenced web page, contact your distributor or contact Defibtech at email@example.com, 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 AEDs. This software upgrade will be able to be installed in the field where the unit is located. 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. Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by FAX at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/Safety/MedWatch/default.htm.