Class 2 Device Recall SOMATOM Sensation 10

• Date Initiated by Firm: September 28, 2004
• Date Posted: November 03, 2004
• Recall Status: Terminated on September 04, 2008
• Recall Number: Z-0162-05
• Recall Event ID: 30173
• 510(K)Number: K013522
• Product Classification: System, X-Ray, Tomography, Computed - Product Code JAK
• Product: SOMATOM CT System Sensation 10, Computed Tomography X-Ray System, Model Number 75 43 015
• Code Information: Serial Numbers: 53001, 53009, 53014, 53054, 53069, 53081, 53084, 53085, 53091, 53096, 53100, 53119, 53126, 53128, 53135, 53139, 53144, 53145, 53147, 53151, and 53154
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Roland Richter,; 610-448-1777
• Manufacturer Reason for Recall: Calcium Scoring feature on this devices is not closing properly after patient's exams.
• FDA Determined Cause: Other
• Action: The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
• Quantity in Commerce: 21 units
• Distribution: The product was shipped to medical facilities nationwide and government account in IL.
• 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