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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An anomaly was identified with eclipse treatment planning system using pencil beam convolution (pbc) 11.0.31 to compute a conventional arc dose distribution. when using pbc 11.0.31 to calculate the does for a conventional arc field with more than 100 segments with eclipse versions 11.0 13.0 13.5 or 13.6 the displayed dose does not correspond to the calculated monitor units (mu). all affected devices in canada are at version 11.0.
Model Catalog: (Lot serial: none); Model Catalog: VERSION 13.5 (Lot serial: none); Model Catalog: VERSION 13 (Lot serial: none); Model Catalog: TPC001001001 (Lot serial: none)