FDA-Device2022-07-13Class II
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
Siemens Medical Solutions USA, Inc
Hazard
After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.
Sold states
US Nationwide.
Affected count
127 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1339-2022Don't want to check this manually?
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