Carl Zeiss Meditec AG recalls 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). Cat

Recalled February 11, 2015 · FDA recall Z-1049-2015 · Carl Zeiss Meditec AG

Hazard

Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data. · FDA Class II

Units

985

Sold at

Nationwide Distribution.

Description

Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.

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.

Manufacturer(s)

Carl Zeiss Meditec AG

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →