Z-1049-2015Class II

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...

Name: Z-1049-2015 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...
Creator: Carl Zeiss Meditec AG
Published: 2015-01-22
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2015-01-22 / Terminated / root cause: software

FDA source

Carl Zeiss Meditec AG began a recall of 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... on 2015-01-22. FDA classified it as Class II and gives the reason as "Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1049-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-22
Posted: 2015-02-04
Terminated: 2016-03-04
Recalling firm: Carl Zeiss Meditec Inc
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.
Product code: NFJ System, Image Management, Ophthalmic
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.
Root cause tag: software
FDA 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 in commerce: 985
Distribution: Nationwide Distribution.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1049-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1049-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-04

Product code NFJ

K122938Class IIForum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG / cleared 2012-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)