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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There is potential for solvent to leak at the atmospheric pressure ionization (api) source and ingress into the instrument. there is a remote possibility that the solvent will ignite creating a potential fire hazard. this issue resulted from a design change. there have been no reports of solvent ignition in the field. if ignition were to occur it is unlikely that the fire would be able to self sustain.