Recall Z-1049-2015 ยท NFJ System, Image Management, Ophthalmic
Carl Zeiss Meditec AG
FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management system.
| Date | Feb 4, 2015 (initiated Jan 22, 2015) |
| Status | Terminated |
| Reason | Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data. |
| Root cause | Software in the Use Environment |
| Action | Important Field Corrective Action for Forum Viewer letters were sent to all affected US customers on January 22, 2015 by certified mail. |
| Quantity | 985 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122938 | FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH Carl Zeiss Meditec, AG, Nov 2, 2012 |