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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This recall is to address a potential issue where the buffer device component could incorrectly process the footswitch signal if power to the component device was lost through the manual tripping of a breaker. the incorrectly processes footswitch signal even though there is no operation interaction would potentially allow the laser to commence firing.