Philips issues recall of select Heartstart Fr2+ automated external defibrillators

Philips is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable.

Models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical, and manufactured between May 2007 and January 2008, are included in the voluntary recall.

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.

Philips has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during routine self tests, not during emergency use of the AED.

Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated, although Philips has received no reports of injury associated with this chip failure.

The AEDs affected by this recall have been distributed globally to fire departments, emergency medical services, hospitals, and other organizations. 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.

Any adverse events experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site.

Philips is offering a new FRx as your replacement device. It includes a free carry case, 1 set of pads, battery, and fresh 5-year warranty.

The HeartStart FRx is the newest member of the HeartStart family of defibrillators and it offers a host of valuable benefits. It is a smaller, lighter unit than FR2+ and it uses the same 1-2-3 layout of the FR2+. The FRx offers the same reliable SMART Analysis and SMART Biphasic therapy.

Learn how FRx is a great choice for FR2+ customers.

Exchange your affected unit for a new FRx, with free carry case, 1 set of pads, battery and fresh 5-year warranty.

Alternatively, you may replace your affected unit(s) with a refurbished FR2+ device that will carry the remainder of the warranty of your current device (approximately 3 years for most affected units). If you choose a refurbished FR2+ as a replacement device, no additional accessories will be provided.

Exchange your affected unit with a refurbished FR2+.