Device 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.
Z-1853-2021
Product summary
- Event
- Event 87904
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1853-2021
Official wording
Reason: Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Code information: Serial Numbers: 14399319, 15508962, 18782712, 18855856
Distribution pattern: US Nationwide distribution in the states of MI, KS, MO, TX.
Derived failure modes
-
Device software or design
software error