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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This update provides a corrective action in regards to the ceiling base rotation brake for select artis systems. special screws will be used for the brake adjustment. this corrective action is to address an issue with a component (adjustment screw supplied with a thread lock): a batch of non-compliant components was delivered (thread lock was missing.