Siemens ARTIS pheno X-ray System
Siemens recalls ARTIS pheno X-ray system over dose display error.
If you use an ARTIS pheno system, contact Siemens Medical Solutions immediately for instructions on verifying dose display accuracy and scheduling a software update or service. Do not use the system for patient examinations until the issue is resolved.
Why it was recalled
Siemens Medical Solutions is recalling the ARTIS pheno interventional fluoroscopic x-ray system because during patient examinations, the system may sporadically display a zero x-ray dose administered to the patient, even though an actual x-ray dose is applied. This behavior has been observed during fluoroscopy and single-frame acquisitions, potentially leading to unintended radiation exposure.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Recall # | UDI-DI |
|---|---|---|
| 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 | Z-2206-2026 | 4056869063317, 4056869295923, 4056869149325 |
| ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | Z-2205-2026 | 4056869046877 |
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Siemens Medical Solutions USA, Inc
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification