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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Pentax america inc. is issuing new instructions for use (ifu) for two rigid laryngostroboscope models 9106 and 9108. this new ifu clarifies the reprocessing instructions in order to ensure that customers are aware of the best methods for cleaning their 9106 and 9108 endoscopes. to ensure all customers have updated information these new ifus are being sent to all customers who have purchased.