—#139817

Product

SOMATOM Definition Edge; 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: K143401
Affected lot / code info: Model#' 10590000 with Serial numbers 83277 83281 83021 83004 83014 83276 83279

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 #139817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.