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 reliance endoscope processing system (reps) is intended for washing and high level disinfection of up to two manually pre-cleaned immersible reusable heat-resistantsemi-critical devices such as gi flexible endoscopes bronchoscopes and their accessories. steris corporation is providing an urgent product safety notice to inform affected customers of an important change in the reliance endoscope processing system instructions for use when processing fujinon g5 and g8 type flexible gi endoscopes. this notice excludes fujinon model ec-530h l and ec-530ls gi endoscopes and does not affect use of the reliance eps to process any other manufacturer's qualified endoscopes.