FDA recall Z-0608-2020

Philips North America, LLC · Class II · device

Product

HeartStart XL+ Defibrillator/Monitor, Model 861290

Reason for recall

Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.

Distribution

US Nationwide

Key facts

Status: Terminated
Initiation date: 2019-10-03
Report date: 2019-12-11
Termination date: 2023-04-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0608-2020