Philips Healthcare is conducting a voluntary recall of a limited number of HeartStart automated external defibrillators (AEDs). This voluntary recall of specific HeartStart OnSite and Home Defibrillators (HS1) and HeartStart FRx AEDs is being conducted with the knowledge of the appropriate Regulatory Agencies.
The recalled devices contain a component called a relay that may not meet Philips performance standards. The relays are from a single manufacturing lot. Possible contamination on the relay surface could compromise its performance over time and affect the AED's ability to make a therapy decision during use. No other Philips defibrillators are affected by this action.
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 relay failure in affected devices that have been shipped. Although the devices subject to this recall are not expected to experience the issue, 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 and HeartStart Home defibrillators. The units affected by the recall were manufactured by Philips in March 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 FRx or HS1 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 of the same model to be shipped to you at no charge. Your replacement unit will carry a full-term warranty. 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 HeartStartRelayAction@philips.com. Outside of North America, please contact your local Philips representative.