FDA-Device2022-01-19Class II
SOMATOM Definition Edge -Computed tomography system Model 10590000
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
N/A
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM Definition Edge -Computed tomography system Model 10590000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0475-2022More Siemens Medical Solutions USA, Inc recalls
- FDA-Device2026-07-08ARTIS icono ceiling. Model Number: 11328100.
- FDA-Device2026-07-08ARTIS icono floor. Model Number: 11327700.
- FDA-Device2026-07-08ARTIS icono biplane. Model Number: 11327600.
- FDA-Device2026-07-08ARTIS icono ceiling. Model Number: 11328100.
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