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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There is a potential malfunction that could occur on the biograph mct or biograph mct flow pet/ct system. this malfunction may cause a display freeze during ct interventional procedures. this issue only occurs on systems running petsyngo vg50a and equipped with the adaptive 3d intervention option.