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 corporation is issuing an urgent device correction for the ak 98 hemodialysis machines listed below. baxter has identified that an incorrect cable was installed in the affected ak 98 machines. if the user connects the machines to the ethernet network a leakage of currents higher than specified values may occur. these units do not have and are not intended to have ethernet functionality. baxter will be correcting the affected units by providing a cap for the ethernet connectors to block the connection.