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Abbott Laboratories Inc. (St Jude Medical) recalls v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a
Recalled June 23, 2021 · FDA recall Z-1853-2021 · Abbott Laboratories Inc. (St Jude Medical)
Hazard
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. · FDA Class II
Units
4 units
Sold at
US Nationwide distribution in the states of MI, KS, MO, TX.
Description
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
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.
Manufacturer(s)
Abbott Laboratories Inc. (St Jude Medical)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →