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Siemens Medical Solutions USA, Inc recalls syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as foll
Recalled July 13, 2022 · FDA recall Z-1339-2022 · Siemens Medical Solutions USA
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. · FDA Class II
Units
127 units
Sold at
US Nationwide.
Description
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.
Product
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
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →