FDA recall Z-0498-2020

Product

HeartStart XL+ Defibrillator/Monitor, Model 861290

Reason for recall

The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user.

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2019-10-16

Report date

2019-11-27

Termination date

2023-11-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0498-2020