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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Emotion 6

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  Class 2 Device Recall SOMATOM Emotion 6 see related information
Date Initiated by Firm August 05, 2008
Date Posted September 21, 2008
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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