FDA-Device2026-01-14Class IIPROCESSING DEFECT
Siemens LUMINOS Lotus Max and dRF Max X-ray systems recalled for incorrect collimation
What this means
Siemens LUMINOS Lotus Max and Luminos dRF Max X-ray systems with software version VF11 may show incorrect collimation (beam positioning) when quickly switching between organ programs. This affects only systems with a bucky wall stand for mobile detectors and no ceiling stand.
- If you operate one of these systems, contact Siemens Medical Solutions USA immediately for guidance
- Do not switch rapidly between organ programs until you receive instructions from Siemens
- Keep documentation of your system model and software version available
The agency's original wording
Hazard
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
Intended for
All ages
Illnesses reported
None reported
Sold states
U.S. and OUS
Affected count
U.S.: 1, OUS: 95
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0999-2026More Siemens recalls
- FDA-Device2026-07-08Siemens ARTIS icono ceiling model 11328100 recalled for loss of movement capability
- FDA-Device2026-07-08Siemens ARTIS icono biplane recalled for potential loss of movement after detector adjustment
- FDA-Device2026-07-08Siemens ARTIS icono floor recalled for potential movement loss at detector height limits
- FDA-Device2026-07-08Siemens ARTIS icono ceiling monitor suspension recalled for loose screw risk
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