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 are software issues in the affected product. 1-when reopening a bookmark generated from processing a muga (multi-gated acquisition) scan within the nm cardiac application the ejection fraction (ef) may be different. 2-when processing using one of the following nm clinical applications: autoquant emory cardiac toolbox corridor4dm or neuroq the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory. note: the data presented to the reviewing physician is the data for the patient presented by the application labeling. 3-while using the nm viewer application an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out. 4-while displaying pet images within ct viewer the suv results displayed may be calculated with an suv method different from the one specified in system preferences. this issue affects the ct viewer and multi-modality tumor tracking applications.