FDA Medical devices recall ·
MICRO-X Rover Mobile X-ray System, # MXU-RV35 recall
- Recall number
- Z-0580-2025
- Date
- (initiated October 22, 2024)
- Company / brand
- Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade, Tonsley, Australia - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
Distribution
US: TX, PR, MD, CA
States: California Maryland Puerto Rico Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0580-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.