Philips FR2+ Corrective Action
Specific Philips HeartStart FR2+ Devices
Philips Healthcare is conducting a voluntary recall of a limited number of the HeartStart FR2+ automated external defibrillators. This voluntary recall is being conducted with the knowledge of the appropriate Regulatory Agencies.
These devices may contain a memory chip that has a higher than expected rate of failure. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated.
In all cases reported to date, the problem has been detected by the FR2+ during a periodic self-test or a battery insertion test. There have been no reported incidents of the problem during emergency use of the AED, and no injuries to users or patients. As a precaution, however, we are proactively retrieving units that may contain the defective chips.
Philips will be replacing affected devices at no charge.
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.
We are sending letters to 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 FR2+ Exchange Form at right to initiate the product replacement process.
If you have not received a letter but are concerned that your device may be affected, we have provided a Search Affected Devices tool, at right. Simply enter the serial number of your FR2+ 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 FR2+ 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 inconveniences caused by this problem. 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 Healthcare at 1-800-263-3342 or by email at FR2PlusAction@philips.com. Outside of North America, please contact your local Philips or Laerdal representative, as appropriate.
You can choose a new FRx as your replacement device.
Includes 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.
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+.
*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.
Serial Number Search
Choose Your Replacement
Key Questions & Answers
Optional FR2+ Exchange Form
Download the FR2+ Exchange Form. Use of the form is optional. If you have already provided the information requested about your affected unit, please do not use this form.