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Philips Healthcare is conducting a voluntary recall of a limited number of the HeartStart HS1 product family (sold as HS1, OnSite, Home, or First Aid ) automated external defibrillators.
Philips has found that in the recalled units, the On/Off or Shock button on the front panel may stick in place when pressed and fail to respond to a button press more often than expected. This behavior has been found only in a very small number of the recalled units, and only during testing. There have been no reported incidents of a button sticking during emergency use of the AED. Our investigation has determined that adverse health consequences are very unlikely as a result of this issue. The majority of devices subject to this recall are not expected to experience the problem. However, the potential difficulty in operating the defibrillator buttons does not meet Philips performance expectations.
Identifying affected devices
Affected devices are models M5066A, M5067A, and M5068A units manufactured in September 2005, with serial numbers beginning with A05I (capital letter A, digits 05, capital letter I). Only units with a serial numbers beginning with A05I are included in this voluntary recall. No other Philips defibrillators are affected by this action.
We have written 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 HS1 Exchange Form at right to initiate the product replacement process.
If you have not received a communication 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 HS1 and click Check Serial Number(s). If your device is affected, you will be directed to contact Philips or complete the on-line HS1 Retrieval form. Philips will arrange for a replacement device to be shipped to you at no charge. When you receive the replacement unit, use the box to return your current device to Philips. If your device is not on the list, no further action is required.
We sincerely regret the inconvenience that this will cause you. Philips has a well-earned reputation for providing products and services of the highest quality. Your satisfaction with Philips products and with our handling of this matter is very important to us.
If you have any questions regarding this action, please contact Philips Healthcare at
1-800-263-3342, option 5
or by email at HS1Action@philips.com.
Outside of North America, please contact your local Philips representative.
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