# FDA recall Z-2206-2026

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2026-03-09.

## Product

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

## Reason for recall

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.

## Distribution

US and Worldwide

## Key facts

- **Recall number:** Z-2206-2026
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-09
- **Report date:** 2026-06-10

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2206-2026

## Citation

> MORVS. FDA recall Z-2206-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2206-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*