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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Philips has become aware that when using the qlab auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications to calculate end-systolic volume (esv) the reported esv may be smaller esv calculated by manual tracing without the use of qlab. correspondingly the left ventricular ejection fraction (ef) calculated using these applications may be higher than the ef calculated by manual tracing without the use of qlab. philips' investigation has found that this difference may occur in cases where the ef is less than approximately 40%.