Recall Z-0580-2025— Micro-X Ltd.
Class II · Ongoing
Class II FDA medical device recall by Micro-X Ltd., initiated 2024-10-22. It names one FDA 510(k) clearance: K211423. Product: MICRO-X Rover Mobile X-ray System, # MXU-RV35. Reason: 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..
- Recalling firm
- Micro-X Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-22
- Firm location
- Tonsley, Australia
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.