Device product
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
Z-2591-2017
Product summary
- Event
- Event 77249
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47 sites have the potentially affected versions
- Official record key
device-enforcement:Z-2591-2017
Official wording
Reason: When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
Code information: Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.