FDA-Device2022-04-27Class II
Artis zee floor, Model Number 10094135
Hazard
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
Sold states
US Nationwide.
Affected count
305 systems
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Artis zee floor, Model Number 10094135
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0967-2022More 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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