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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens SOMATOM Definition Edge

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 Class 2 Device Recall Siemens SOMATOM Definition Edgesee related information
Date Initiated by FirmNovember 15, 2016
Create DateDecember 12, 2016
Recall Status1 Terminated 3 on April 27, 2018
Recall NumberZ-0744-2017
Recall Event ID 75812
510(K)NumberK152036 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductSOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
Code Information Model # 10590000 Serial Numbers: 65127 95798 73739 83277 66219 65491 65453 95738 96357 65615 73726 66467 64860 73860 65712 65304 65437 65614 65856 96305 73296 73831 83403 73840 64709 96335 73673 65639 95003 65501 96351 73778 96028 96316 83520 96288 66396 96238 96352 96324 96336 65480 96312 95768 73777 95955 73883 83399 73783 96226 96303 96047 65609 73791 73887 73071 96266 95701 74368 83537 73895 96214 95925 96347 96061 83533 74226 74297 65760 74376 65017 65516 73162 64065 65455 83524 66041 65618 73818 66066 73028 83306 65680 65734 73905 95797 65672 73886 96302 83398 73538 95717 96053 65972 95278 96326 96327 96286 95447 74200 74289 96364 95510 64140 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMarlynne Galloway
610-448-6471
Manufacturer Reason
for Recall		Software update that provides software and firmware bug-fixes to improve system performance
FDA Determined
Cause 2		Software Design Change
ActionSiemens mailed a Customer Information Letter to affected customers on November 21, 2016 informing them of software updates that would provide bug-fixes to improve system performance and stability for customers with SOMATOM Definition AS, Definition Edge and Definition Flash systems using Software versions VA48A_SP1 and VA48A_SP2. The update will remotely be pushed to their systems or customers will be contacted by one of Siemens service organization to arrange a date for installation of the update on site. Customers with questions were instructed to call 1-800-888-7436.
Quantity in Commerce104 systems
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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