Device product
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Z-0611-2017
Product summary
- Event
- Event 75497
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 sites potentially have the affected versions
- Official record key
device-enforcement:Z-0611-2017
Official wording
Reason: Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
Code information: Versions 3.0.1, 3.1, and 3.2
Distribution pattern: Distribution was made to medical facilities nationwide. Foreign distribution was also made.
Derived failure modes
-
Device software or design
Software displayed incorrect