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FDA-Device2026-01-14Class IIPROCESSING DEFECT

Siemens LUMINOS Lotus Max and dRF Max X-ray systems recalled for incorrect collimation

Siemens
OTHERNationwide distribution

Contact Siemens about your LUMINOS X-ray system

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
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.

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-0999-2026

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