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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A problem was found during production with the part designed to mechanically connect the c-arm to the stand. due to an unintended external force the front plate in this part broke into two pieces causing the c-arm to suspend on the single central bolt. if this problem were to reoccur in the field it could pose a risk for patients and others in close vicinity to the system.