FORUM Archive and Viewer…

Date

Feb. 11, 2015

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

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.

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.

Distribution pattern

Nationwide Distribution.

Quantity

985

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)

Recall started

Jan. 22, 2015

Device type

System, Image Management, Ophthalmic

Root cause (FDA)

Software in the Use Environment

What the company told customers

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

Recall number

Z-1049-2015

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1049-2015. The agency record governs; check it and the company before acting.