FDA-Device2021-01-20Class II
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Hazard
When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.
Sold states
Worldwide-US Nationwide
Affected count
5602
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0656-2021More Siemens Medical Solutions USA, Inc recalls
- FDA-Device2026-07-08Siemens ARTIS icono ceiling monitor suspension recalled for loose screw risk
- FDA-Device2026-07-08Siemens ARTIS icono floor recalled for potential movement loss at detector height limits
- FDA-Device2026-07-08Siemens ARTIS icono biplane recalled for potential loss of movement after detector adjustment
- FDA-Device2026-07-08Siemens ARTIS icono ceiling model 11328100 recalled for loss of movement capability
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