FDA-Device2016-05-04Class II
SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
Siemens Medical Solutions USA, Inc
Hazard
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.
Sold states
US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA
Affected count
37 CTsystems
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1558-2016Don't want to check this manually?
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