Home / Recalls / Philips North America, LLC / Z-2053-2020

Z-2053-2020 Class II Terminated

Recalled by Philips North America, LLC — Andover, MA

Recall Details

Product Type
Devices
Report Date
May 27, 2020
Initiation Date
April 13, 2020
Termination Date
April 7, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
94,034 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide distribution - US Nationwide distribution.

Code Information

All units. Product has been discontinued.

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  • Z-1316-2026 Class II — IQon Spectral CT; Product Code (REF): 728332; (January 7, 2026)
  • Z-1156-2026 Class II — Patient Information Center iX; Software Version Number: 4.5.0 (December 22, 2025)
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