Device product
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Z-0877-2021
Product summary
- Event
- Event 86996
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27
- Official record key
device-enforcement:Z-0877-2021
Official wording
Reason: When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.
Code information: version 1.1
Distribution pattern: Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
Derived failure modes
-
Unknown
When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.