# FDA recall Z-0316-2025

> **SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION** · Class II · device recall initiated 2024-09-06.

## Product

SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.

## Reason for recall

X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

## Distribution

US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.

## Key facts

- **Recall number:** Z-0316-2025
- **Recalling firm:** SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-06
- **Report date:** 2024-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kyoto, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0316-2025

## Citation

> AI Analytics. FDA recall Z-0316-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0316-2025. Source: US FDA. Licensed CC0.

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