Defibtech Announces Class I Recall
Defibtech LLC Guilford, CT is initiating a voluntary worldwide recall of the Lifeline AED® and ReviveR AED™ (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. The company has devised procedure that can be used to keep the device in service. These instructions, and how to determine the software version of your unit, are available at www.defibtech.com/fa2007. Defibtech will provide customers with a free software upgrade to address this issue for all affected AEDs. The software upgrade is expected to be available within the next 10 weeks.
For more information, contact your distributor or contact Defibtech at techsupport@defibtech.com or 1-877-453-4507.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that if the malfunction occurs use product use may cause serious injury or death.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
- Online: www.fda.gov/MedWatch/report.htm
- Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 - FAX: 1-800-FDA-0178
Source: www.fda.gov/cdrh/recalls/recall-021707.html
Posted by Quality America on March 13, 2007 | Comments (0)
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