Recall Z-0664-2025— Micro-X Ltd.
Class II · Ongoing
Class II FDA medical device recall by Micro-X Ltd., initiated 2023-05-31. It names one FDA 510(k) clearance: K211423. Product: MICRO-X Rover Mobile X-ray System, # MXU-RV35. Reason: Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started..
- Recalling firm
- Micro-X Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-31
- 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
Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
Data sourced from openFDA. This site is unofficial and independent of the FDA.