FDA-Device2023-01-25Class II
AXIOM Luminos Agile
Hazard
There is potential for the footrest to detach from the patient table during use.
Sold states
Worldwide distribution
Affected count
271 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
AXIOM Luminos Agile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1001-2023More 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.
- FDA-Device2026-04-22Siemens ARTIS Pheno VE30A and VE40A imaging system recalled for potential unintended radiation exposure
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