Device product
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Z-1180-2017
Product summary
- Event
- Event 76258
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 sites have the potentially affected version
- Official record key
device-enforcement:Z-1180-2017
Official wording
Reason: The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
Code information: Version V8.30.7.8
Distribution pattern: US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
Derived failure modes
-
Unknown
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.