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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:187397

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 recall number

Z-1853-2021

Evidence summary

Product code
DQK
Recall status
Terminated
Event initiated
May 05, 2021
Root cause
Software Manufacturing/Software Deployment
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1853-2021