# FDA recall Z-0580-2025

> **Micro-X Ltd.** · Class II · device recall initiated 2024-10-22.

## Product

MICRO-X Rover Mobile X-ray System, # MXU-RV35

## Reason for recall

Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.

## Distribution

US: TX, PR, MD, CA

## Key facts

- **Recall number:** Z-0580-2025
- **Recalling firm:** Micro-X Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-22
- **Report date:** 2024-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tonsley, Australia

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0580-2025

## Citation

> AI Analytics. FDA recall Z-0580-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0580-2025. Source: US FDA. Licensed CC0.

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