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Terminated

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.

FDA Recall Z-1049-2015 · Posted 2015-02-04

Recalling FirmCarl Zeiss Meditec AG
Recall StatusTerminated
Product CodeNFJ
Date Initiated2015-01-22
Date Terminated2016-03-04
Product Quantity985

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.

Firm Action

Important Field Corrective Action for Forum Viewer letters were sent to all affected US customers on January 22, 2015 by certified mail.

Root Cause

Software in the Use Environment

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122938FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCHCarl Zeiss Meditec, AG · 2012-11-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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