—#145086

Product

SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133589
Affected lot / code info: SOMATOM Force Material # 10742326, serial numbers 75550, 75526, 75512, 75567, 75536, 75514, 75563, 75510, 75454, 75540, 75571, 75437, 75500, 75527, 75475, 75535, 75481, 75439, 75450, 75482, 75460, 75493, 75476, 75458, 75528, 75467, 75487, 75478, 75513, 75532, 75555, 75524, 75515, 75559, 75501, 75570, 75576, 75450, 75482, 75528, 75576

Why it was recalled

The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem.

Root cause (FDA determination)

Software design

Action the firm took

Siemens distributed a Safety Advisory Notice dated April 1, 2016, to affected customers The letter identified the affected product, problem, how to avoid potential risks, how the issue will be resolved. and actions to be taken. Customers were asked to observe the safety notice and comply with the corresponding measures until further notice.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA

Timeline

Recall initiated: 2016-04-01
Posted by FDA: 2016-04-22
Terminated: 2017-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145086. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.