Due to recent changes, agfa (b)(4) is now separate from agfa healthcare (b)(4).Agfa (b)(4) is currently awaiting the assignment of a fda registration number.This report has been submitted via the manufacturer registration number 9616389 for agfa healtcare (b)(4).For this report, the mfr report # 9616389-2018-00017 should be 10058267-2018-00002, however due to technical restraints of the esubmitter system, the agfa (b)(4) owner/operator number could not be entered into the mfr report # field.
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A customer in the us reported to agfa when using their dx-d 600 system, the tube was moving at an abnormal speed.The customer reported the tube was moving around the room quickly and not lining up with the board.During the investigation by agfa, agfa service confirmed the system was moving at an abnormal speed in the transversal direction.Agfa service replaced the tachometer, which controls the speed of the unit the transversal direction.Agfa service tested the unit and auto centered the unit three times to the wall and table with normal transversal speed movement.The unit is now working as intended.There has been no reported harm to patient or user during these events.
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