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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Addition of temperature sensor to stop r1 overheating if k2 contactor fails.
Model Catalog: (Lot serial: Model # 16 42 086 SN 8077); Model Catalog: (Lot serial: Model # 47 62 469 SN 8680); Model Catalog: (Lot serial: Model # 47 62 469 SN 8526)