Class 2 Device Recall SOMATOM Emotion 6

• Date Initiated by Firm: August 05, 2008
• Date Posted: September 21, 2008
• Recall Status: Terminated on November 07, 2008
• Recall Number: Z-2452-2008
• Recall Event ID: 49139
• 510(K)Number: K023687
• Product Classification: Computed tomography x-ray system. - Product Code JAK
• Product: SOMATOM Emotion 6. Computed tomography X-ray system
• Code Information: Model Numbers: 10165888, 10165977, and 10046789.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Michael Van Ryn; 610-448-4634
• Manufacturer Reason for Recall: Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to open in the event of a short circuit condition between the internal switch contacts.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm issued and Safety Update in July 2008 informing users that the firm will have representatives visit each account to replace the cap per Update Instructions CT032/08/S.
• Quantity in Commerce: 53 units
• Distribution: Nationwide including states of AK, AL, CO, FL, GA, IA, ID, IL, IN, LA, MD, MN, MS, NC, NE, NY, OH, OK, OR, RI, SD, TX, UT, 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