Rover Mobile X-ray System recall — FDA Z-1670-2025
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Overview of recall records associated with Micro-X Ltd., including dates, categories and classifications where available.
Classification mix: Class II: 8.
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
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 hardware and how different…
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 prep/expose switch, the prep…
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 dry time, Atmospheric…
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 may impede radiation exposure…
This page summarizes recall records in which the official source identifies Micro-X Ltd. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.