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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Leica microsystems schweiz informed the importer that an electronic component of the leica m525 oh4 and leica m720 oh5 surgical microscopes with 400w illumination could lead to an unforeseen behavior. an electronic component in one of the two illumination units can potentially overheat resulting in modest smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope. the observed malfunction can only occur on devices that include a 400w power supply type hbx400.