Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI
FDA Recall Z-0826-2008 · Posted 2008-02-07
Recalling FirmXoran Technologies, Inc.
Recall StatusTerminated
Product CodeJAK
Date Initiated2008-01-04
Date Terminated2010-10-22
Product Quantity71
Reason for Recall
Misbranding; These devices do not bear the manufacturer's name or address.
Firm Action
Consignees were notified via letter, Urgent Medical Device Correction, dated 1/4/08 of the need to apply proper labeling to the products, and were sent instructions and labeling to affix to their units.
Root Cause
Labeling design
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.