Recall Z-1828-2017 ยท NFJ System, Image Management, Ophthalmic
Merge Healthcare, Inc.
Merge Eye Station and Merge Eye Care PACS.
| Date | Apr 4, 2016 |
| Status | Terminated |
| Reason | During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently. |
| Root cause | Software in the Use Environment |
| Action | The recalling firm issued a letter dated 3/28/2016 via email the week of 4/4/2016 or via certified mail if they did not have an email address for the customer. A second letter dated 7/11/2016 was issued to nonresponders. |
| Quantity | 1,627 sites potentially have the affected versions |
| Distribution | Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution. |
| FDA record | Open on fda.gov |