Device product
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity 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-1385-2017
Product summary
- Event
- Event 76471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 sites potentially have the affected software
- Official record key
device-enforcement:Z-1385-2017
Official wording
Reason: The software is not adding the correct tomo image.
Code information: Versions 11.0 and 11.0.1
Distribution pattern: US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.
Derived failure modes
-
Unknown
The software is not adding the correct tomo image.