Official recall record
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 113
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-03-09
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 4056869063317
- Brand on record
- Siemens Medical Solutions USA, Inc
- Product category
- Medical Device
What the authority reported
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2025-05-15 · US FDA — Medical Devices
interventional fluoroscopic x-ray system
Other recalls from this brand
- 2026-03-12 · US FDA — Medical Devices
ARTIS Pheno VE30A and VE40A, Model 10849000 - 2026-03-10 · US FDA — Medical Devices
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. - 2026-03-09 · US FDA — Medical Devices
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
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