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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge

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 Class 2 Recall
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge
see related information
Date Posted February 03, 2014
Recall Status1 Open
Recall Number Z-0907-2014
Recall Event ID 67138
Premarket Notification
510(K) Numbers
K103127  K113342  K120579  K122471 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Code Information models 8098027, 7740769, 10430603, 10590000, with multiple serial numbers: 64789, 64492, 66767, 66649, 64067, 66182, 65364, 64673, 64419, 66518, 66243, 64368, 64081, 60398, 66929, 66327, 66146, 66188, 66355, 66467, 64860, 64342, 73579, 73813, 64179, 66498, 64172, 66433, 66572, 66768, 64790, 66193, 64270, 66503, 65013, 65014, 64821, 64337, 64734, 65036, 66455, 66451, 66928, 65403, 65597, 64770, 66964, 66924, 64082, 66151, 66911, 65576, 67017, 64481, 64694, 66844, 73366, 64430, 65302, 64624, 66458, 60124, 66667, 64913, 64834, 73642, 66618, 66396, 66473, 73499, 64194, 64455, 60121, 64260, 66183, 64536, 83056, 64478, 65044, 60331,64424, 73738,64103,64232,64299,66851,66404,64929,64591,83014, 64114, 66381, 60404, 67000, 66422, 64181, 66490, 66738, 65225, 64308, 66253, 64822, 64484, 66757, 66679, 66616, 83059, 66813, 64603, 73679, 66695, 66878, 65948, 65572, 66248, 64304, 83044, 73160, 64019, 66375, 66689, 60173, 73030, 73655, 64504, 73818, 66112, 64882, 65341, 64243, 64297, 64378, 66824, 64370, 64340, 66445, 73547, 66462, 66882, 73761, 66316, 64927, 66694, 66700, 64071, 66634, 64827.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall
During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.
FDA Determined
Cause 2
DESIGN: Software Design
Action A recall notification letter, dated November 15, 2013, was sent to Users.
Quantity in Commerce 147
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 SOLUTIONS USA INC.
510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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