| 2026-03-27 |
Class II
|
Ongoing |
Z-1918-2026 |
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 |
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X-Ray generator may malfunction resulting in the X-Ray being inoperable. |
| 2025-04-04 |
Class II
|
Ongoing |
Z-1670-2025 |
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X… |
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Potential for internal fastening mechanism within generator of mobile x-Ray to fail. |
| 2025-04-04 |
Class II
|
Ongoing |
Z-1669-2025 |
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rov… |
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Potential for internal fastening mechanism within generator of mobile x-Ray to fail. |
| 2025-03-28 |
Class II
|
Ongoing |
Z-1579-2025 |
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile … |
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Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. |
| 2025-03-28 |
Class II
|
Ongoing |
Z-1578-2025 |
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile … |
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Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0666-2025 |
MICRO-X Rover Mobile X-ray System, # MXU-RV19 |
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During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the p… |
| 2024-10-22 |
Class II
|
Ongoing |
Z-0580-2025 |
MICRO-X Rover Mobile X-ray System, # MXU-RV35 |
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Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation d… |
| 2023-11-28 |
Class II
|
Ongoing |
Z-0665-2025 |
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71 |
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Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator. |
| 2023-05-31 |
Class II
|
Ongoing |
Z-0664-2025 |
MICRO-X Rover Mobile X-ray System, # MXU-RV35 |
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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… |
| 2022-08-31 |
Class II
|
Ongoing |
Z-1786-2022 |
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 |
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Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which… |