FDA-Device2018-03-07Class II
SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to
Siemens Medical Solutions USA, Inc
Hazard
The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
Sold states
US Nationwide Distribution in the states of FL, MO, NY, TN
Affected count
1
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0714-2018Don't want to check this manually?
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