FDA-Device2022-01-19Class II
SOMATOM Confidence -Computed tomography systems Model 10590100
Siemens Medical Solutions USA, Inc
Hazard
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Sold states
US Nationwide distribution.
Affected count
108 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM Confidence -Computed tomography systems Model 10590100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0472-2022Don't want to check this manually?
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