Class 2 Device Recall Biograph mCTS 64

• Date Initiated by Firm: August 11, 2009
• Date Posted: November 10, 2009
• Recall Status: Terminated on December 22, 2009
• Recall Number: Z-0164-2010
• Recall Event ID: 53453
• 510(K)Number: K060631
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment.
• Code Information: serial numbers: 1002 and 1003
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA Inc.; 810 Innovation Dr; Knoxville TN 37932-2562
• For Additional Information Contact: Maria Ebio; 865-218-2532
• Manufacturer Reason for Recall: In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.
• FDA Determined Cause: Device Design
• Action: Siemens Medical Solutions USA, Inc. issued an "Urgent Field Correction - Recall" notice to consignees by letter dated September 3, 2009 informing them of the problem and that a Siemens service representative will be in contact shortly to service the affected product. For further information, contact Siemens at 1-800-888-7436.
• Quantity in Commerce: 2 units
• Distribution: Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong.
• 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