FDA recall Z-2157-2020

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.

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide distribution and the countries of China, Republic of Korea, Netherlands, Norway, United Kingdom.

Key facts

Status

Terminated

Initiation date

2020-04-27

Report date

2020-06-03

Termination date

2021-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2157-2020