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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Philips has become aware that the dose may be inconsistent with the density of a density-overriden roi (region of interest). the issue occurs under certain specific conditions where the user modifies a contour in a density-overridden roi (region of interest with density set to a specific value) in a computed plan dose is subsequently invalidated and the user may recompute the dose. in this case the density can be replaced by the ct number from the ct to density table when recomputed resulting in an incorrect dose and the monitor units (mu) may then be much higher than origianlly planned. the user may continue and save the plan with incorrect dose. when the plan is reopened the density is reported as the correct value but the dose remains incorrect based on the prior incorrect value for density.