FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1049-2015
- Recalling firm
- Carl Zeiss Meditec AG
- 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.
- Status
- Terminated
- Initiated
- 2015-01-22
- Posted
- 2015-02-04
- Terminated
- 2016-03-04
- 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.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K122938"]
- PMA numbers
- not on file
- Product code
- NFJ
- Firm FEI
- 3001362763
- Firm city
- Jena
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28