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.
데이터 추가 비고
원인
Tomotherapy has discovered an anomaly during internal testing. if a tomodirect procedure which consists of 2 to 12 beam angles has an unrecoverable interrupt or emergency stop during a short time period between beam angles there is a small possibility that the procedure will indicate a "performed" status rather than "interrupted" on the operator station. if this occurs the user will not be able to generate a completion procedure. tomotherapy's investigation revealed that when an unrecoverable interrupt or emergency stop occurs with <1 second remaining in a tomodirect beam angle the logic in the software code checks if all the triggers (beam pulses) for the current beam angle is fully delivered and marks the procedure as "performed" rather than interrupted as intended. the anomaly is not taking into account if there are any remaining beam angles to be delivered.