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.
This recall has been terminated (originally issued February 4, 2015).
- Recall Initiated
- January 22, 2015
- Posted
- February 4, 2015
- Terminated
- March 4, 2016
- Recall Number
- Z-1049-2015
- Quantity
- 985
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
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)
Root Cause
Software in the Use Environment
Action Taken
Important Field Corrective Action for Forum Viewer letters were sent to all affected US customers on January 22, 2015 by certified mail.
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