FDA-Device2015-03-18Class II
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: 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.
Siemens Medical Solutions USA, Inc
Hazard
Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ECG handling with visual feedback of correct placement of ECG leads and contact quality, and other safety related issues.
Sold states
US Nationwide Distribution in the states of PA, MA, MN, NY, SC, MD, NY, IL, OH, TX and KY.
Affected count
12
Manufactured in
40 Liberty Blvd, Mail Code: 65-1A, Malvern, PA, United States
Products
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2015Don't want to check this manually?
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