The field service tech of a distributor reported to midmark that during a field service to a preva x-ray unit, serial number (b)(4), he found that the unit generated a short x-ray exposure for approximately 200 milliseconds when it is turned on.The x-ray unit operated as intended after it was turned on.
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The field service engineer of the distributor performed an on-site investigation with remote support from midmark on (b)(6) 2014.The field service engineer reported that the failure was repeatable, and was eliminated after the control unit was replaced.The control unit was then returned to midmark for further investigation on (b)(6) 2014.However, the failure could not be replicated at midmark.The control unit passed all functional tests and visual inspection, and operated as intended at midmark.Midmark also performed schematic review and concluded that the reported failure mode cannot be caused by a single fault condition (i.E.Single component failure).
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