Device product
ClearCanvas RIS/PACS
Z-1758-2020
Product summary
- Event
- Event 85216
- Status
- Terminated
- Classification
- Class II
- Quantity
- 903 units
- Official record key
device-enforcement:Z-1758-2020
Official wording
Reason: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Code information: ClearCanvas RIS/PACS, partt number SYN-0524 with versions 3.0 and higher. Unique Device Identifier (UDI)# (01)00670082000115 (10)1x1
Distribution pattern: US
Derived failure modes
-
Device software or design
software defect