FDA-Device2023-01-25Class II

AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF

Siemens Medical Solutions USA, Inc
Hazard

There is potential for the footrest to detach from the patient table during use.

Sold states
Worldwide distribution
Affected count
654 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1000-2023

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