Approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs) are being recalled by Philips Healthcare. According to the recall notice, a potential memory chip failure may render the device inoperable.
The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy.
The recall involves only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May 2007 and January 2008. The AEDs affected by this recall have been distributed globally to fire departments, emergency medical services, hospitals, and other organizations.
Philips said it has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated. These reported failures were detected during routine self tests, and Philips has received no reports of injury associated with this problem.
Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs by sending notification letters to distributors and users. In addition, the company has set up a page on the Philips Web site with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is.
Philips has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Customers who have questions about the recall or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.
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October 22nd, 2009 at 7:47 am
Does this issue affect the new FR3, what’s the status of the FR3 currently? Is it approved already? If not, is there any estimated date for that? Thanks in advance.