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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Tantalum capacitor c5 was installed backwards during assembly which may result in premature failure. failure may result in immediate reset of the monitor or shutdown of the device without an alarm.
Model Catalog: 6004013 (Lot serial: SN AJ07080006); Model Catalog: 6004013 (Lot serial: SN AJ07080007); Model Catalog: 6004013 (Lot serial: SN AJ08010004)