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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In case of an unikely failure of a brake the c-arm of the system may descend on the patient or operator. the risk of a failure of the brake and the associated potential hazard for patients or operators is specific for the stated software versions (vc14 vc20 or vc21) in conjunction with a specific configuration for the artis zeego system.