Class 2 Device Recall SOMATOM Emotion 6

• Date Initiated by Firm: June 04, 2015
• Date Posted: June 27, 2015
• Recall Status: Terminated on March 24, 2017
• Recall Number: Z-1934-2015
• Recall Event ID: 71484
• 510(K)Number: K133424
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: SOMATOM Emotion 6; 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 numbers: 10165888 with serial numbers: 29161 29185 29186 29165 29176 29181 29198
• 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: A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
• FDA Determined Cause: Device Design
• Action: A safety advisory notice, dated June 4, 2015, was sent to direct accounts explaining the problem and potential risk to patients and operators. Siemens engineers will begin replacing the bolts in May 2015.
• Quantity in Commerce: 40 total
• Distribution: Nationwide Distribution.
• 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