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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When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam on the plan were not updated by the system. these depths were incorrect and led to an incorrect dose calculation. the erroneous dose was not delivered to the patient therefore serious injury did not occur.
Model Catalog: SOFTWARE VERSION 3.1 (Lot serial: C202); Model Catalog: SOFTWARE VERSION 3.0 (Lot serial: C202); Model Catalog: SOFTWARE VERSION 3.5.0 (Lot serial: C202); Model Catalog: SOFTWARE VERSION 3.5.1 (Lot serial: C202)