FDA recall Z-1853-2021

Abbott Laboratories Inc. (St Jude Medical) · Class II · device

Product

v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.

Reason for recall

Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

Distribution

US Nationwide distribution in the states of MI, KS, MO, TX.

Key facts

Status
Terminated
Initiation date
2021-05-05
Report date
2021-06-23
Termination date
2024-06-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1853-2021