FDA recall Z-2137-2020

Product

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

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 including in the states of KY, MA, ND, NY and the countries of United Kingdom, Bahrain.

Key facts

Status

Terminated

Initiation date

2020-04-21

Report date

2020-06-03

Termination date

2021-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2137-2020