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
As a result of investigation into complaints related to the treatment table (txt) that is part of the linear accelerators the following safety issues were identified: 1. in very rare instances the actual table position may significantly deviate from the position at the table side control and the linac control console but no interlock occurs. 2. in sporadic cases the following issue for the table axis lateral longitudinal and isocentric rotation occurs: after a manual table movement with released brake an immediate automatic movement for the same table axis is not possible.