Device product
DR Systems Unity PACS software, now known as Merge Unity PACS
Z-1426-2017
Product summary
- Event
- Event 76541
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 sites potentially have the affected version
- Official record key
device-enforcement:Z-1426-2017
Official wording
Reason: Reports were missing demographic header information when they were faxed to referring physicians.
Code information: Version 11.0
Distribution pattern: US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
Reports were missing demographic header information when they were faxed to referring physicians.