Company: Carl Zeiss Meditec AG
Date of Enforcement Report 2/11/2015
Class lI:
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.
Recall Number Z-1049-2015
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/MANUFACTURER
Carl Zeiss Meditec AG, Jana, DE on 1/22/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
985
DISTRIBUTION
Nationwide.
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