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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Spacelabs has received multiple reports of the non-invasive blood pressure (nibp) parameter becoming non-functional with an associated message (no reading). in addition there is one of the following three error messages: inflate error hw error or no data. spacelabs is not aware of any injuries related to this issue.