FDA-Device2021-06-23Class II
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.
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.
Sold states
US Nationwide distribution in the states of MI, KS, MO, TX.
Affected count
4 units
Manufactured in
1 Saint Jude Medical Dr, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1853-2021Don't want to check this manually?
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