Z-1049-2015 Class II Terminated
FDA device recall Z-1049-2015 was initiated by Carl Zeiss Meditec AG on January 22, 2015 and is designated Class II. 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. The recall status is terminated (terminated March 4, 2016). Affected quantity: 985.
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2015
- Initiation Date
- January 22, 2015
- Termination Date
- March 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 985
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.
Distribution Pattern
Nationwide Distribution.
Code Information
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)