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 problem was identified through the supplier's internal quality system on a production lot. at issue is the lack of an adequate silicone seal around the periphery of the attenuator enclosure which houses an in-line series of resistors designed to restrict the level of energy being transmitted to a pediatric recipient during defibrillation.