Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

A brand of external defibrillators designed for use during sudden cardiac arrest is being recalled by the manufacturer because the devices may fail, rendering them inoperable and preventing them from delivering therapy when needed, according to the Food and Drug Administration (FDA) MedWatch reporting system.

The recall, which covers about 5,400 Philips Heartstart Fr2+ Automated External Defibrillators, known s AEDs, follows reports of a memory chip failure which could render the AEDs inoperable. AEDs are used by trained responders and designated responders and designated response teams to help treat sudden cardiac arrest.

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

Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs. The company has also set up a page on its Web site, www.philips.com/FR2PlusAction, with a serial number look-up tool that allows customers to find out if their FR2+ device is part of the recall. Instructions on what to do if the device is among the recalled units also is included on the Web site.

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 at www.fda.gov/medwatch.

This entry was posted on Thursday, October 8th, 2009 at 7:00 am and is filed under product liability, recalled products. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.