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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jun 10, 2026

ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model...

Full official product description

ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

Verification delayed

The last verified facts remain visible. Last successful verification: Jul 31, 2026, 3:43 PM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system; ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

Identifiers to compare

  • UDI 4056869063317
  • UDI 4056869295923
  • UDI 4056869149325
  • UDI 4056869046877
  • Model 11327600
  • Model 11328100
  • Model 11327700
  • Model 10849000
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventi...ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325Not listedZ-2206-2026
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray systemUDI: 4056869046877Not listedZ-2205-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

US and Worldwide

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.