# FDA recall Z-1814-2026

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2026-03-12.

## Product

ARTIS Pheno VE30A and VE40A, Model 10849000

## Reason for recall

During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

## Distribution

U.S. and O.U.S.

## Key facts

- **Recall number:** Z-1814-2026
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-12
- **Report date:** 2026-04-22

- **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-1814-2026

## Citation

> AI Analytics. FDA recall Z-1814-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1814-2026. Source: US FDA. Licensed CC0.

---

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