FORUM Archive and Viewer — Class II medical device recall Z-1049-2015
Terminated recall by Carl Zeiss Meditec AG, reported 2015-02-11, distributed nationwide. Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical co
| Recall number | Z-1049-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec AG, Jena, N/A, Germany |
| Recall initiated | 2015-01-22 |
| Classified | 2015-02-04 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2016-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 985 |
| Reason classes | software |
| Model numbers | 000000-20107-750 |
Product
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.
Reason for recall
Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1049-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.