FDAApril 13, 2020device

Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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