Z-0580-2025 Class II Ongoing
FDA device recall Z-0580-2025 was initiated by Micro-X Ltd. on Oct 22, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2024
- Initiation Date
- Oct 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
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 Pattern
US: TX, PR, MD, CA
Code Information
UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0580-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026