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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An anomaly has been identified with the head ring posts (4 each per site) used by both the optical guidance platform (ogp) frame array module where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failure during usage. this could result in the movement of the head ring relative to the patient's anatomy.