Class 2 Device Recall SYS IVK, Bio mCTS(40) 3R4R, Model Number 10250743

• Date Initiated by Firm: July 14, 2015
• Date Posted: August 05, 2015
• Recall Status: Terminated on March 03, 2016
• Recall Number: Z-2334-2015
• Recall Event ID: 71712
• 510(K)Number: K123737
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
• Code Information: SERIAL NUMBER 11004
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA Inc.; 810 Innovation Dr; Knoxville TN 37932-2562
• For Additional Information Contact: Service representatives; 865-218-2000
• Manufacturer Reason for Recall: Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
• FDA Determined Cause: Packaging change control
• Action: The firm initiated their recall on 07/14/2015 by telephone to the sole US consignee. The update is scheduled for 07/15/2015.
• Quantity in Commerce: 1 unit
• Distribution: Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.
• 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 = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.