Device product
Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
Z-2551-2016
Product summary
- Event
- Event 74846
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 sites potentially have the affected version
- Official record key
device-enforcement:Z-2551-2016
Official wording
Reason: The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
Code information: Version 11.0
Distribution pattern: US Distribution to states of: CA, PA, TX, and MT.
Derived failure modes
-
Unknown
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.