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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Baxter has identified that subsequent to a prior device field correction in 2003-2004 some model 1550 hemodialysis instruments may have replacement circuit boards with incorrect versions of software. the correct versions of software are 4.1b (for system 4 instruments) and 3.0a (for system 3 instruments). a small number of replacement boards may also be affected.