REVOLUTION CT - MAIN UNIT (2016-04-21) — recall 55366
Health Canada — Medical Devices · Canada · 2016-05-16 · Type II
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Reported risk: GE Healthcare has become aware that an out of tolerance torque tool was used on three joints on revolution CT system during the manufacturing process. If the x-ray tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. There have been no injuries reported as a result of this issue.
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