Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in AustraliaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Micro-X Ltd. with 10 device recalls, 2 510(k) clearances and 1 warning letter. The most recent is a device recall dated Mar 27, 2026: Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 27, 2026 | Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71Class II · X-Ray generator may malfunction resulting in the X-Ray being inoperable. | Device recalls |
| Apr 4, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("RoverClass II · Potential for internal fastening mechanism within generator of mobile x-Ray to fail. | Device recalls |
| Apr 4, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays SysClass II · Potential for internal fastening mechanism within generator of mobile x-Ray to fail. | Device recalls |
| Mar 28, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("RoveClass II · Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. | Device recalls |
| Mar 28, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("RoveClass II · Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. | Device recalls |
| Oct 23, 2024 | MICRO-X Rover Mobile X-ray System, # MXU-RV19Class II · During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the | Device recalls |
| Sep 10, 2024 | Warning letter: CAPA, Complaint handling, MDR reportingCDRH | Warning letters |
| Nov 28, 2023 | MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71Class II · Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator. | Device recalls |
| May 31, 2023 | MICRO-X Rover Mobile X-ray System, # MXU-RV35Class II · Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve d | Device recalls |
| May 21, 2021 | RoverK211423 · IZL | 510(k) clearances |
| Jul 17, 2020 | RoverK201488 · IZL | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
