Class 3 Device Recall Xoran MiniCAT for ENT.

• Date Initiated by Firm: January 04, 2008
• Date Posted: February 07, 2008
• Recall Status: Terminated on October 22, 2010
• Recall Number: Z-0826-2008
• Recall Event ID: 45532
• 510(K)Number: K032243
• Product Classification: Computed Tomography X-Ray System. - Product Code JAK
• Product: Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI
• Code Information: All units
• FEI Number: 3004198450
• Recalling Firm/ Manufacturer: Xoran Technologies, Inc.; 309 N 1st St; Ann Arbor MI 48103-3301
• For Additional Information Contact: 800-709-6726
• Manufacturer Reason for Recall: Misbranding; These devices do not bear the manufacturer's name or address.
• FDA Determined Cause: 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 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 = JAK