# FDA recall Z-0317-2025

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

## Product

The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.

## 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-0317-2025
- **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-0317-2025

## Citation

> AI Analytics. FDA recall Z-0317-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0317-2025. Source: US FDA. Licensed CC0.

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