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U.S. Department of Health and Human Services

Class 2 Device Recall FORUM Archive and Viewer

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  Class 2 Device Recall FORUM Archive and Viewer see related information
Date Initiated by Firm January 22, 2015
Date Posted February 04, 2015
Recall Status1 Terminated 3 on March 04, 2016
Recall Number Z-1049-2015
Recall Event ID 70365
510(K)Number K122938  
Product Classification System, image management, ophthalmic - Product Code NFJ
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.
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)
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec AG
Carl Zeiss Promenade 10
Jena Germany
For Additional Information Contact Judith A. Brimacombe, M.A.
925-557-4616
Manufacturer 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.
FDA Determined
Cause 2		 Software in the Use Environment
Action Important Field Corrective Action for Forum Viewer letters were sent to all affected US customers on January 22, 2015 by certified mail.
Quantity in Commerce 985
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NFJ and Original Applicant = CARL ZEISS MEDITEC AG
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