Device product
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Z-0939-2017
Product summary
- Event
- Event 75876
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 sites potentially have the effected software
- Official record key
device-enforcement:Z-0939-2017
Official wording
Reason: The software fails to associate to the correct MG image if there are two images for the same view.
Code information: Version 11.0
Distribution pattern: Distribution was made to medical facilities located in MT, CA, PA, and TX.
Derived failure modes
-
Device software or design
software fails to