Class 2 Device Recall SOMATOM Force

• Date Initiated by Firm: December 03, 2014
• Date Posted: January 14, 2015
• Recall Status: Terminated on April 06, 2015
• Recall Number: Z-0971-2015
• Recall Event ID: 69957
• 510(K)Number: K133589
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
• Code Information: Model number: 10742326, serial numbers 75437, 75454, 75464, 75450, 75467, 75475, 75439.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Customer Support; 610-219-6300
• Manufacturer Reason for Recall: Artifacts are found in acquired imaging on the SOMATOM Force.
• FDA Determined Cause: Software Manufacturing/Software Deployment
• Action: A customer advisory notice, dated December 3, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were informed that new software would be installed via remote access.
• Quantity in Commerce: 7
• Distribution: PA, MA, MN, SC, MD, and TX.
• 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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.