—#132029

Product

SOMATOM Force; the intended use of computed tomography is 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 angels 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: K133589
Affected lot / code info: Model number: 10742326, serial numbers 75437, 75454, 75464, 75450, 75467, 75475, 75439.

Why it was recalled

Artifacts are found in acquired imaging on the SOMATOM Force.

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

A customer advisory notice, dated December 3, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were informed that new software would be installed via remote access.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: PA, MA, MN, SC, MD, and TX.

Timeline

Recall initiated: 2014-12-03
Posted by FDA: 2015-01-14
Terminated: 2015-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132029. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.