Philips Medical Systems is conducting a voluntary recall of a limited number of HeartStart FR2+ automated external defibrillators (AEDs). This voluntary recall being conducted with the knowledge of the appropriate Regulatory Agencies.
The recalled devices contain a component called a voltage detector from lots that have been found to exhibit a higher than expected rate of failure. Failure of the voltage detector can cause the AED battery to drain more rapidly than normal or to render it unusable when needed in an emergency. No other Philips defibrillators are affected by this action.
In all cases reported to date, the problem has been detected by the FR2+ and shown on the status indicator. There have been no reported incidents of the problem during emergency use of the AED, and no reported injuries to users or patients. The majority of the devices subject to this recall are not expected to experience this problem. However, as precaution, we are retrieving these devices proactively. Philips will be replacing affected devices at no charge. As a courtesy, Philips will also be providing a new battery with each replacement unit.
Identifying affected devices
Affected models are M3840A and M3841A (distributed by Laerdal Medical) and M3860A and M3861A. The units affected by the recall were manufactured by Philips and distributed between May 2007 and May 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 contact Philips 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 Medical Systems.
In North America, call 1-800-263-3342 and select option 6, or email FR2FieldAction@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.