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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Siemens became aware of an incident with a linear accelerator oncor where an autosequence was set up with a treatment management system. during the autosequence the gantry collided with the patient's head while moving. the patient received a wound on the head that resulted in skin injuries but no further damage. the user provided a detailed report in which he described that a mistake was made when selecting the beams for autosequence. the user error caused the unintended motion and hence the injury.