Carl Zeiss Meditec FORUM Archive and Viewer Software Recall
Carl Zeiss Meditec is recalling FORUM Archive and Viewer software versions 3.1 and 3.2 due to a defect that may lead to misinterpretation of optical coherence tomography data.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the misinterpretation of medical imaging data, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Carl Zeiss Meditec AG is recalling 985 units of the FORUM Archive and Viewer software, versions 3.1, 3.1.1, 3.2, and 3.2.1. The affected products are distributed in DVD and USB flash drive formats and are used as an ophthalmic image management system. The specific catalog numbers for the recalled items are 000000-20107-750, 000000-2058-601, and 000000-2084-928.
The recall was initiated because of a software defect in versions 3.1 and 3.2 that may lead to the misinterpretation of optical coherence tomography (OCT) data. This defect poses a risk to the accuracy of the medical imaging data being reviewed.
The affected units were distributed nationwide. Users of the FORUM Archive and Viewer software should verify their version and contact the manufacturer for further instructions on how to address the defect.
The recalled product
- 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…
- Manufacturer
- Carl Zeiss Meditec AG
- Affected units
- 985
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 000000-2084-928 (USB drive with FORUM 3.2.1)
Distribution
Distributed nationwide across the United States.
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