Disclosures

October 05, 2009

October 5, 2009 (Seattle, Washington) — Phillips Medical has issued a recall of about 5400 of its HeartStart FR2+ automated external defibrillators (AEDs), including some models distributed by Laerdal Medical, "due to the possibility of a memory-chip failure that may render the device inoperable," the company announced last week [1].

The recall affects devices manufactured between May 2007 and January 2008, with model numbers M3860A and M3861A, distributed by Philips, and M3840A and M3841A, distributed by Laerdal Medical.

"In all cases reported to date, the problem has been detected by the FR2+ during a periodic self-test or a battery-insertion test," according to Philips [2]. "There have been no reported incidents of the problem during emergency use of the AED, and no injuries to users or patients." The company says it will replace defective devices at no charge.

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