Device product
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Z-1681-2017
Product summary
- Event
- Event 76309
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,627 sites potentially have the affected software
- Official record key
device-enforcement:Z-1681-2017
Official wording
Reason: The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
Code information: All versions of Eye Care PACS, Eye Station, and ESIU.
Distribution pattern: Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution.
Derived failure modes
-
Unknown
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.