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Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: 8 recalls listed since January 2026 across FDA.

By year

  • 20268

By agency

  • FDA8

By category

  • Medical Device8

All recalls (8)

Siemens ARTIS Icono Ceiling

The ARTIS icono ceiling has a potential issue with the suspension that holds the monitor, and screws may loosen over time.

Moderate risk, FDA, , Device defect

Siemens ARTIS Icono Biplane, Ceiling and Floor

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Moderate risk, FDA, , Device defect

Siemens Artis Pheno and Artis Icono Interventional Fluoroscopic X-Ray Systems

These interventional fluoroscopic x-ray systems may show a 0 dose while actually applying x-ray to the patient.

Moderate risk, FDA, , Device defect

Siemens Artis Pheno Angiography Systems

ARTIS Pheno VE30A and VE40A may capture lighter and darker patient images, causing less accurate 3D reconstruction.

Moderate risk, FDA, , Device defect

Siemens Artis Pheno and Artis Icono Biplane Systems

ARTIS pheno and ARTIS Icono biplane, floor and ceiling may sporadically display a major increase of the x-ray dose applied to the patient.

Moderate risk, FDA, , Device defect

Siemens SOMATOM X.Ceed and NAEOTOM Alpha Software Applications

CT software applications lack FDA clearance and may be removed from certain systems.

Moderate risk, FDA, , Software defect

Siemens LUMINOS Q.Namix R and Q.Namix T Interventional Fluoroscopic X-Ray Systems

Interventional fluoroscopic X-ray systems may not flip ortho images and could process a previous patient's image.

Moderate risk, FDA, , Device defect

Siemens LUMINOS Lotus Max and Luminos dRF Max

Luminos Lotus Max and Luminos dRF Max systems may have incorrect collimation when switching quickly between organ programs.

Moderate risk, FDA, , Software defect
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