FDA Device recall 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 Format)

• FDA Device
• Class II
• terminated
• Published 2015-02-11

On 2015-02-11 the FDA classified a Class II 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) by Carl Zeiss Meditec Ag, citing software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.

Read the official FDA Device notice

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1049-2015%22

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