Reported Feb 11, 2015 · Terminated
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).…
Carl Zeiss Meditec AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carl Zeiss Meditec AG · Carl Zeiss Promenade 10 · Jena, N/A · N/A
Is this the product you have?
FORUM Archive and Viewerversion 3.1v 3.1.1(DVD Format) and v 3.2v 3.2.1.(DVD and USB Flash Drive Format)
- Catalog numbers000000-20107-750 (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
- Lot codes and dates
- Catalog numbers000000-20107-750 (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)
- Amount recalled
- 985
Where it was sold
- Nationwide
Why it was recalled
Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.
This product could cause temporary or reversible health problems — stop using it.
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