Philips Healthcare is conducting a voluntary product removal of a limited number of HeartStart FR2+ automated external defibrillators (AEDs). Philips has informed the U.S. Food and Drug Administration (FDA) of this action.
The AEDs subject to this action may contain a flash memory component that was improperly relabeled by a third party, and therefore Philips cannot with certainty identify the source, quality, and date of manufacture of the component.
Philips does not believe there is a safety hazard associated with the flash memory component. Our investigation has found that the relabeled components are equivalent in functionality to the component we specify. There have been no reported incidents of failure of the component during emergency use of the AED and no reported injuries to users or patients. However, because they have been relabeled, these components do not meet our quality requirements, and we have decided to replace all AEDs that may contain them.
Philips will be replacing the units free of charge.
Identifying affected devices
Affected models are M3860A, M3861A (distributed by Philips), M3840A, and M3841A (distributed by Laerdal Medical) manufactured by Philips and shipped between May 2007 and August 2010. No other Philips defibrillators are affected by this action.
We are contacting directly all customers who, according to our records, have received affected devices. Customers are requested to contact Philips by telephone. If you received a letter but prefer to respond electronically rather than by telephone, please click on the Exchange Form at right to initiate the product replacement process.
If you have not been contacted but are concerned that your device may be affected, we have provided a Serial Number Look-Up tool, at right. Simply enter the serial number of your FR2+ defibrillator and click Check Serial Number(s). If your device is not on the list, no further action is required.
If your device is affected, you will be directed to either contact Philips directly or complete and submit the Exchange form. Philips will arrange for a replacement device to be shipped to you at no charge. When you receive the replacement unit, use the same packaging to return your current device to Philips.
Philips apologizes for any inconvenience this may cause. Your satisfaction with Philips products and with our response to this situation is very important to us.
If you have any questions regarding this action, please contact Philips. In North America, call
1-800-263-3342 and select option 6, or email FR2AEDAction@philips.com. Outside of North America, please contact your local Philips representative.
*The choice of a new FRx as a replacement device is available in USA and Canada only. 5-year warranty is standard in USA and Canada. For other regions, check with your local Philips dealer for warranty details.