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 switch can be activated for a very short time such that the orange ri...
Class IIReported ongoing
Distribution: US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
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 Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (M...
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 timers are started.
Class IIReported ongoing
Distribution: Worldwide and US Nationwide Distribution: NJ, PR, CA
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 management decisions
Class IIReported ongoing
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of CA, NV, NY, OH, TX and WA and the countries of Australia, France, Israel, Japan, and United Arab Emirates.
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
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.
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 switch can be activated for a very short time such that the orange ring of death is displ...
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Checking Micro-X Ltd.
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