Recall Z-0665-2025— Micro-X Ltd.
Class II · Ongoing
Class II FDA medical device recall by Micro-X Ltd., initiated 2023-11-28. It names one FDA 510(k) clearance: K211423. Product: MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71. Reason: Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator..
- Recalling firm
- Micro-X Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-28
- 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; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Reason for recall
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Data sourced from openFDA. This site is unofficial and independent of the FDA.