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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There have been 4 reported instances (not in canada) where servo 1 ventilators have malfuncioned when being used during high dose radio therapy by linear accelerator (linac). they stopped working generated different error codes reset and started again. no permanent damage or harm to the patient occured. we are informing our customers that sorvo-1 and sorvo -s ventilators are not to be used during hight dose radiotherapy by linear accelerator (linac). the manufacturer has never claimed that these devices could be used in this type of environment.