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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens SOMATOM Definition Flash

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  Class 2 Device Recall Siemens SOMATOM Definition Flash see related information
Date Initiated by Firm November 02, 2016
Create Date November 17, 2016
Recall Status1 Terminated 3 on November 08, 2017
Recall Number Z-0608-2017
Recall Event ID 75677
510(K)Number K143416  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Definition Flash, Computed tomography x-ray system
The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are 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 Number: 10430603  Serial Numbers:96020, 96047,74192,83398,96011,83387 96029 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Marlynne Galloway
610-448-6471
Manufacturer Reason
for Recall		 Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.
FDA Determined
Cause 2		 Software design
Action Siemens mailed a Customer Safety Notice on November 9, 2016, to customers who were affected by the recall to inform them of a possible malfunction with the systems. The notification explained the underlying issue, the effect if has on the operation of the system, potential risks involved; and the actions they plan to implement to correct the issues. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6471.
Quantity in Commerce 7 systems
Distribution Nationwide distribution to MI, NY, CA, KY, ND, and NE.
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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