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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The manufacturer is conducting a field corrective action to update the sub cpu firmware of safe-3000 to version 1.30 by replacement of the main pcb after it was determined that older safe 3000 processors may not work properly with 30/70k endoscopes.