| Reason
for Recall: |
Defibtech®,
LLC, is initiating a voluntary worldwide recall of Lifeline®
Semi-automatic External Defibrillators (AEDs) and ReviveR®
Semi-automatic External Defibrillators (AEDs). 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. |
| FDA
Comments: |
Defibtech®,
LLC, initiated notification of its distributors and
customers by letter on February 22, 2007. Defibtech®, LLC,
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®,
LLC, at
techsupport@defibtech.com, 1-877-453-4507 or
1-203-453-4507.
Defibtech®, LLC, 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 ten weeks.
Defibtech®, LLC, 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 AED TM” on the front of the device.
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.
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.
For more information about
this recall, please see the company’s press release at
http://www.defibtech.com/news/2007_0307_recall.html.
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