medical Class II Updated 2021-06-23

Abbott Laboratories Inc. (St Jude Medical) recalls v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Cla

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 14399319, 15508962, 18782712, 18855856
View official government recall

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