Philips Voluntary Medical Device Recall

Philips Healthcare is conducting a voluntary recall of a limited number of HeartStart automated external defibrillators (AEDs) produced in October 2009. This voluntary recall of specific OnSite, First Aid, HS1, and Home defibrillators (HS1) and FRx defibrillators is being conducted with the knowledge of the appropriate Regulatory Agencies. 

These devices contain a capacitor that may not meet our quality standards. Failure of the capacitor during use could prevent the AED from delivering effective defibrillation therapy when indicated.

This issue was discovered in the Philips factory during monitoring and analysis of our manufacturing processes. At this time, we have received no reports of capacitor failure in the affected devices that have been shipped. Although most of the devices subject to this recall are not expected to experience the problem, the potential for this failure does not meet Philips performance expectations. As a precaution, we are proactively retrieving all units that may contain a defective capacitor.

Philips will be replacing affected devices at no charge.

Identifying affected devices
Affected devices are HS1 (models M5066A and M5068A) and FRx (model 861304) automated external defibrillators. The HS1 defibrillators are sold in North America as HeartStart OnSite and HeartStart Home, and internationally as HeartStart HS1, HeartStart First Aid or HeartStart Home defibrillators. The units affected by the recall were manufactured by Philips in October 2009. No other Philips defibrillators are affected by this action.

We are writing directly 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 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 Serial Number Look-Up tool, at right. Simply enter the serial number of your HS1 or FRx 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 your Philips representative or complete and submit the Exchange form (the exchange form is for customers with US and Canada Ship-To addresses only). 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.  In North America, call 1-800-263-3342 and select the Recall menu option or email HeartStartCapacitorAction@philips.com.  Outside of North America, please contact your local Philips representative.