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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Definition Flash

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  Class 2 Device Recall SOMATOM Definition Flash see related information
Date Initiated by Firm August 14, 2015
Date Posted October 05, 2015
Recall Status1 Terminated 3 on December 05, 2016
Recall Number Z-0020-2016
Recall Event ID 72091
510(K)Number K143416  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Definition Flash; 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# 10430603 with Serial numbers 73476 73586 73544 73648 73636 73621 73533 73423 73424 73520 73493 73459 74191 73487 73492 73494 73497 73013 73657 73535 73667 73490 73513 74192 73697 73635 73471 73405 73600 73558 73591 73546 73478 73504 73413 73674 73445 73547 73420 73430 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
FDA Determined
Cause 2		 Software design
Action A customer advisory notice, dated 8/14/15, was sent to direct accounts advising them of the issue to observe the safety notice and comply with the corresponding measure until the update has been fully completed.
Quantity in Commerce 113 total
Distribution Nationwide Distribution.
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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