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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B

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 Class 2 Recall
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B
see related information
Date Posted March 14, 2013
Recall Status1 Terminated on January 31, 2014
Recall Number Z-0948-2013
Recall Event ID 64376
Premarket Notification
510(K) Number
K122471 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Code Information Model numbers - 7740769, 8098027, 10430603, and 10590000.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Meredith Adams
610-448-3237
Manufacturer Reason
for Recall
Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.
FDA Determined
Cause 2
DESIGN: Software Design
Action Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" dated November 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The correction for this problem will be available with Service Pack 1 for syngo CT2011A And Service Pack 4 for syngo CT2012B. Both Service pack are planned to be released starting February 2013. Systems still running on syngo CT2010A or syngo CT2010B are already scheduled to be upgraded to syngo CT2011A or syngo CT2012B respectively. Contact your local Siemens Application Specialist for additional information.
Quantity in Commerce 896
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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