—#140167

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K143416
Affected lot / code info: 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

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 #140167. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.