Date Initiated by Firm | August 14, 2015 |
Date Posted | October 05, 2015 |
Recall Status1 |
Terminated 3 on December 05, 2016 |
Recall Number | Z-0021-2016 |
Recall Event ID |
72091 |
510(K)Number | K143400 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | SOMATOM Definition AS, 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#' 8098027 with Serial numbers 66441 95601 95610 65831 65868 95596 95600 95604 65968 66506 95043 95582 65764 95602 66146 65578 95584 66476 95578 66467 95609 66503 66475 66455 65597 65233 95599 64942 65446 66396 95474 66304 66423 66473 66473 95438 95581 66232 66173 66404 95491 66514 66321 65583 65586 66457 66490 66253 95579 66579 95593 95575 95592 66001 66407 95580 65693 66112 66470 95591 95559 66434 66230 95608 95510 66303 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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