Home / Recalls / Medical Devices
Philips North America, LLC recalls Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for
Recalled June 3, 2020 · FDA recall Z-2157-2020 · Philips North America
Hazard
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections · FDA Class II
Units
260 units
Sold at
Worldwide distribution - US Nationwide distribution and the countries of China, Republic of Korea, Netherlands, Norway, United Kingdom.
Description
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Product
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.
Manufacturer(s)
Philips North America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →