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Micro-X Ltd. FDA Recalls
10 recalls on file across devices, 0 of them Class I and 10 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71Class IIMar 27, 2026X-Ray generator may malfunction resulting in the X-Ray bein |
| Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: RovClass IIApr 4, 2025Potential for internal fastening mechanism within generator |
| Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile XClass IIApr 4, 2025Potential for internal fastening mechanism within generator |
| Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile Class IIMar 28, 2025Potential for early life x-ray tube failure for mobile x-ray |
| Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile Class IIMar 28, 2025Potential for early life x-ray tube failure for mobile x-ray |
| MICRO-X Rover Mobile X-ray System, # MXU-RV19Class IIOct 23, 2024During internal testing it was found that if the system is R |
| MICRO-X Rover Mobile X-ray System, # MXU-RV35Class IIOct 22, 2024Mobile x-ray system receiving/storage(operation) requirement |
| MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71Class IINov 28, 2023Mobile x-ray system can report and deliver a lower post-expo |
| MICRO-X Rover Mobile X-ray System, # MXU-RV35Class IIMay 31, 2023Shots were terminated by the mAs integrator; however, the 4 |
| MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19Class IIAug 31, 2022Software calibration error with product equip with a Dose Ar |