Medical device recalls Moderate risk

Philips North America, LLC recalls Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for…

Recall date
April 27, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2157-2020
FDA classification
Class II
Brand / firm
Philips North America, LLC
Sold / distributed
Worldwide distribution - US Nationwide distribution and the countries of China, Republic of Korea, Netherlands, Norway, United Kingdom.

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 MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.

Get recall alerts

Free email alert whenever Philips North America, LLC has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Philips North America, LLC