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Corrective Action for HeartStart FR3, Philips

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 01636/12

Philips Healthcare has issued a Field Safety Notice concerning a corrective action of the HeartStart FR3 automated external defibrillators (AEDs), model numbers 861388 and 861389, distributed between May 24 and September 13, 2011. A software update is required in order to adress two urgent issues: 1. A power cycle may leave the device in an activated but unresponsive state unless the battery is removed and reinstalled. 2. During the language load process a language may be loaded onto the FR3 that is different than the language selected by the user.

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