Recall Z-1681-2017 ยท NFJ System, Image Management, Ophthalmic
Merge Healthcare, Inc.
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
| Date | Mar 13, 2017 (initiated Apr 4, 2016) |
| Status | Terminated |
| Reason | The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. |
| Root cause | Software Design Change |
| Action | The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. |
| Quantity | 1,627 sites potentially have the affected software |
| Distribution | 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. |
| FDA record | Open on fda.gov |