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U.S. Department of Health and Human Services

Class 3 Device Recall Xoran MiniCAT for ENT.

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 Class 3 Recall
Xoran MiniCAT for ENT.
see related information
Date Posted February 07, 2008
Recall Status1 Terminated on October 22, 2010
Recall Number Z-0826-2008
Recall Event ID 45532
Premarket Notification
510(K) Number
K032243 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI
Code Information All units
Recalling Firm/
Manufacturer
Xoran Technologies, Inc.
309 N 1st St
Ann Arbor, Michigan 48103-3301
Manufacturer Reason
for Recall
Misbranding; These devices do not bear the manufacturer's name or address.
FDA Determined
Cause 2
DESIGN: Labeling Design
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.
Quantity in Commerce 71
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = XORAN TECHNOLOGIES, INC.
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