FDAMay 5, 2021device

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 ca...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

abbott laboratories inc st jude medicalabbottabbott laboratories

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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