—#151034

Product

SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are 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 Number: 10430603 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029

Why it was recalled

Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.

Root cause (FDA determination)

Software design

Action the firm took

Siemens mailed a Customer Safety Notice on November 9, 2016, to customers who were affected by the recall to inform them of a possible malfunction with the systems. The notification explained the underlying issue, the effect if has on the operation of the system, potential risks involved; and the actions they plan to implement to correct the issues. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6471.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution to MI, NY, CA, KY, ND, and NE.

Timeline

Recall initiated: 2016-11-02
Terminated: 2017-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151034. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.