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 manufacturer has discovered a problem with warmair 135 convective warming devices manufactured between mar 2003 and nov 2010. the manufacturer discovered the printed circuit board on those devices is mounted inside the device using metal instead of plastic studs causing devices to not comply with the creepage distance and air clearance requirement outlined in iec 60601-1.