medical Class II Updated 2020-05-27

Philips North America, LLC recalls Philips HeartStart XL Defibrillator/Monitor (Model number M4

Recalled Product

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 or on the order of a physician.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All units. Product has been discontinued.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →