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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM CT System

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  Class 2 Device Recall SOMATOM CT System see related information
Date Initiated by Firm March 09, 2006
Date Posted April 26, 2006
Recall Status1 Terminated 3 on July 19, 2006
Recall Number Z-0795-06
Recall Event ID 34872
510(K)Number K040665  
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system.
Code Information Sensation 40 model number 8874427 with serial numbers 57021, 57028, 57015, 57037, 57001, 57038, 57019 and Sensation 64 model number 8377520 with serial numbers 54219, 54508, 54060, 54436, 54482, 54437, 54188, 54407, 54154, 54051, 54422, 54530, 54528, 54056, 54445, 54480, 54489, 54556, 54560, 54418, 54463, 54016, 54534, 54404, 54064, 54488, 54269, 54416, 54529, 54305 and 54210
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 2		 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 38 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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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