Philips North America, LLC recalls Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualif…

Recall date

April 13, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2053-2020

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

Worldwide distribution - US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.