Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Imr cardiac - irregular appearance of contrast in vessels missing image annotation's in cct halo artifacts incorrect z annotation on plan box for coronal/sagittal surviews unintended change of acquisition timing on scan ruler bolus tracker does not trigger as expected system unresponsive when paused system becomes unresponsive during timed scan unplanned results during multi-phase pulmo series may cause a system crash communication errors between host computer & gantry incorrect phase tolerance for cardiac step & shoot error when auto roi placement outside patient anatomy no "go" when hr outside of acceptable range console unresponsive when gantry cancels scan unable to match z locations on prescan and 4d ct scan pin wheel artifact using 0.67mm slice width tracker scan halted with fdom. (please contact manufacturer for details regarding reasons for recall).