Siemens ARTIS pheno and ARTIS Icono biplane systems recalled for inaccurate x-ray dose display
What this means
Siemens ARTIS pheno and ARTIS Icono biplane imaging systems may occasionally display an incorrect, higher x-ray dose reading during patient exams. The actual radiation dose delivered is safe and meets regulatory standards, but the displayed reading can be misleading. This affects certain model numbers used in hospitals and imaging centers.
- If you operate or manage one of these systems, contact Siemens Medical Solutions USA immediately for guidance
- Do not stop using the system; actual radiation levels are safe
- Ask Siemens for software or firmware updates to correct the dose display
The agency's original wording
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1653-2026More 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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