Class 2 Device Recall SOMATOM CT System

• Date Initiated by Firm: March 09, 2006
• Date Posted: April 26, 2006
• Recall Status: Terminated on July 19, 2006
• Recall Number: Z-0794-06
• Recall Event ID: 34872
• 510(K)Number: K013522
• Product Classification: System, X-Ray, Tomography, Computed - Product Code JAK
• Product: SOMATOM CT System Sensation 16. Computed tomography x-ray system.
• Code Information: Sensation 16 model number 7393114 with serial numbers 50693, 51600, 51570, 50882 and 51573
• 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: When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.
• FDA Determined Cause: Other
• Action: The recalling firm has issued a software patch to the affected customers per Update Instructions CT086/05/S and CT087/05/S. By letter 3/9/2006. In addition, a Siemens Service Engineer will visit affected sites to install this software patch which will resolve this issue.
• Quantity in Commerce: 5 units
• Distribution: Nationwide. The product was shipped to AK, AZ, CA, DE, FL, GA, IL, IN, KY, LA, MD, ME, MI, MT, NC, NY, OH, OK, PA, PR, TX, UT, VA, WA and WI.
• 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