# FDA recall Z-1653-2026

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2026-03-10.

## Product

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

## Reason for recall

During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient.  Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system  settings and imaging conditions, as well as the applicable regulatory requirements.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1653-2026
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-10
- **Report date:** 2026-04-15

- **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-1653-2026

## Citation

> AI Analytics. FDA recall Z-1653-2026. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1653-2026. Source: US FDA. Licensed CC0.

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