Device product
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
Z-1470-2017
Product summary
- Event
- Event 76654
- Status
- Terminated
- Classification
- Class II
- Quantity
- 187 sites potentially have the affected versions
- Official record key
device-enforcement:Z-1470-2017
Official wording
Reason: The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.
Code information: iConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0.
Distribution pattern: USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.
Derived failure modes
-
Device software or design
software produced a number of "do not route" exceptions, which may result in