FDA-Device2022-04-27Class II
Artis zee floor MN, Model Number 10094142
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
24 systems
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Artis zee floor MN, Model Number 10094142
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0971-2022More 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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