Micro-X Ltd.

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.

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 displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.

Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.

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.

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, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.