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

Recall date

April 21, 2020

Source

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

Recall number

Z-2137-2020

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of KY, MA, ND, NY and the countries of United Kingdom, Bahrain.

Why it was recalled

HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections

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 Monitor/Defibrillators 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