Device product
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Z-1762-2017
Product summary
- Event
- Event 76910
- Status
- Terminated
- Classification
- Class II
- Quantity
- 333 sites potentially have the affected versions
- Official record key
device-enforcement:Z-1762-2017
Official wording
Reason: An error message can occur resulting in the prior studies being unavailable for viewing.
Code information: Versions : 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.1 HF0557, 8.40.s, 8.40.2.1, 8.40.2.2, 8.80, 8.80.0.1, 8.80.1.1, 8.80.2, 8.80.0.2, 9.0.0, 9.0.0.1, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.1.2.2, 9.2.0, 9.3.0, 9.3.1, 9.4.0, 9.4.1, 9.4.2, 9.4.2.1., and 9.4.3
Distribution pattern: Distribution was made nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government/military distribution was also made.
Derived failure modes
-
Unknown
An error message can occur resulting in the prior studies being unavailable for viewing.