Device product
Fusion Workstation.; Indicated for the transmission and review of radiological images.
Z-0294-2017
Product summary
- Event
- Event 75425
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 sites potentially hae the affected version
- Official record key
device-enforcement:Z-0294-2017
Official wording
Reason: After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
Code information: Versions V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1.
Distribution pattern: Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.
Derived failure modes
-
Unknown
After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.