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Class 3 Device Recall Xoran MiniCAT for ENT. |
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Date Initiated by Firm |
January 04, 2008 |
Date Posted |
February 07, 2008 |
Recall Status1 |
Terminated 3 on October 22, 2010 |
Recall Number |
Z-0826-2008 |
Recall Event ID |
45532 |
510(K)Number |
K032243
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Product Classification |
Computed Tomography X-Ray System. - Product Code JAK
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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 MI 48103-3301
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For Additional Information Contact |
800-709-6726
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Manufacturer Reason for Recall |
Misbranding; These devices do not bear the manufacturer's name or address.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = XORAN TECHNOLOGIES, INC.
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