Recall Z-1246-2017 ยท NFJ System, Image Management, Ophthalmic
Merge Healthcare, Inc.
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
| Date | Mar 28, 2016 |
| Status | Terminated |
| Reason | Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN) |
| Root cause | Device Design |
| Action | The recalling firm issued a letter dated 3/28/2016 via e-mail. If no email address was available, the letters were issued via certified mail. A follow-up letter dated 7/11/2016 was also issued. |
| Quantity | 1,627 sites potentially have the affected versions |
| Distribution | Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada. |
| FDA record | Open on fda.gov |