—#140168

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K143400
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2015-08-14
Posted by FDA: 2015-10-05
Terminated: 2016-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140168. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.