Device product
Synaptive ImageDrive Clinical
Z-1759-2020
Product summary
- Event
- Event 85216
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 units
- Official record key
device-enforcement:Z-1759-2020
Official wording
Reason: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Code information: ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1
Distribution pattern: US
Derived failure modes
-
Device software or design
software defect