Health Canada — Medical Devices · Canada · 2024-12-30 · Type II
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Reported risk: Philips has identified that due to the forces applied during the movement of the c-arc of the Azurion and Allura systems, the bolts supporting the FlexMove carriage may become loose and/or break, and cracks may appear in the FlexMove carriage. If FlexMove rail fixation bolts become loose or broken, or cracks appear in the carriage, the following issues may occur: • transversal movements of the c-arc stop due to false collision detections because of additional friction. • manual movement of the FlexMove carriage not possible due to added friction. • abnormal noise during transversal movement of the c-arc. • unstable c-arc suspension. • fall of the c-arc assembly (1,500 kg), if all bolts in the x-axis would break/get loose. • drop of the c-arc assembly (up to 10cm if c- arc is at one side of the rail, up to 5 cm if c-arc is in the center of the rails, and 1.5 cm if the c-arc is in the anterior/posterior position), if all bolts in the y-axis would break/get loose. Recall start date: December 12, 2024
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