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SEATTLE — Philips said Monday it is recalling about 5,400 HeartStart FR2 automated external defibrillators due to a possible memory chip failure that could make the device unable to work properly.
The defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest.
Only certain defibrillators are included in the recall. They are the FR2 AEDs distributed by Philips that have model numbers M3860A and M3861A, as well as others distributed by Laerdal Medical with model numbers M3840A and M3841A. All recalled models were made between May 2007 and January 2008.
The Dutch firm, known formally as Royal Philips Electronics, said it has had no reports of any injuries. The defects were detected in internal tests, the company said.
The devices subject to recall have been purchased by fire departments, emergency medical service people, hospitals and other groups across the globe. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs by sending notification letters to distributors and users.
Customers can also use a serial number look-up tool on the Philips Web site — http://www.philips.com/FR2PlusAction — to find out if their FR2" is part of this recall.
Philips said it has notified the U.S. Food & Drug Administration of its decision to voluntarily recall the affected product. Customers who have questions or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.
