Recall Z-1049-2015— Carl Zeiss Meditec AG

Name: FDA recall Z-1049-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-22

Class II · Terminated

Class II FDA medical device recall by Carl Zeiss Meditec AG, initiated 2015-01-22, terminated 2016-03-04. It names one FDA 510(k) clearance: K122938. 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..

Recalling firm: Carl Zeiss Meditec AG
Classification: Class II
Status: Terminated
Initiated: 2015-01-22
Terminated: 2016-03-04
Firm location: Jena, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K122938 — FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCHCarl Zeiss Meditec, AG·cleared 2012-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.