Recall Z-2754-2017 ยท NFJ System, Image Management, Ophthalmic
Merge Healthcare, Inc.
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image
| Date | Jul 10, 2017 (initiated Jun 13, 2017) |
| Status | Terminated |
| Reason | When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD. |
| Root cause | Software design |
| Action | The firm initiated the recall by certified letter the week of 06/26/2017. The notice provided the work-around and requested a response. |
| Quantity | 18 units |
| Distribution | FL, IL, CO, MI, CA, NY, ND, OH, CT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110006 | OIS SYMPHONY IMAGE MANAGMENT SYSTEM Ophthalmic Imaging Systems, May 18, 2011 |