Micro-X Ltd. recalls Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

X-Ray generator may malfunction resulting in the X-Ray being inoperable.

On March 27, 2026, Micro-X issued a Urgent: Medical Device Correction Notification, via E-Mail. Micro-X ask consignees to take the following actions: " Contact your local service representative to arrange replacement of the PCBA with the updated version at the next scheduled visit or Preventative Maintenance. In the interim, customers may continue to use the device. " To minimize the likelihood of system failure, the batteries should not be permitted to fully discharge. Any system errors or abnormal behaviours must be reported to your authorised service provider without delay. " If the product has been further distributed to other facilities, please ensure this notice is immediately shared with them. " Please complete and email the Customer Response Form in Appendix 1 to the Micro-X LTD in Australia: djerkovic@micro-x.com and copy support@micro-x.com Completing this form confirms receipt of this notice, understanding of the issue, and the necessary actions to be taken.

• FDA enforcement recordOfficial FDA database entry for Z-1918-2026
• FDA 510(k) clearance · K211423The device's official FDA premarket clearance record
• FDA device classification · IZLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1720The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Micro-X Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.