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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Use of the software tool virtual touch tissue imaging quantification (vtiq) on the acuson s2000 and acuson s3000 systems has a potential measurement error. specifically the color mapping is misaligned with the b-mode image underneath. what this results in for the user is a difference between the color mapping and the shear wave velocity readout. the velocity result in m/s does not correspond with the velocity color scale. when repositioning the vtiq region of interest from the original location to a new one the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.