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FDA Medical Device Recalls

Product: Philips HeartStart FR2 Plus Automated External Defibrillator (AED) - The affected devices are models M3840A and M3841A (distributed by Laerdal Medical), and M3860A and M3861A (distributed by Philips). The units affected by the recall were manufactured by Philips between May 2007 and January 2008. No other Philips defibrillators are affected by this action.

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. The web page is www.philips.com/FR2PlusAction

Use: These devices are intended for use by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest (heart attack). The devices analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.

Recalling Firm: Philips

Reason for Recall: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..

Public Contact: Customers may call Philips HeartStart Customer Service at 1-800-263-3342 or email FR2PlusAction@philips.com.

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