Abbott Laboratories Inc. (St Jude Medical) recalls v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" Sy…

Recall date

May 5, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1854-2021

FDA classification

Class II

Brand / firm

Abbott Laboratories Inc. (St Jude Medical)

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, 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.