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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It has been identified that the metalized coating on the is3000 hd lamp module (pn 950093-05) may be incompatible with the illuminator (pn 951183-06) control board leading to an erroneous red preventive maintenance advisory (pma) that shows up on all monitors and cannot be dismissed by the user. this error does not affect the lighting of the lamp module in the normal fashion and there are no reports of lamp failure that have been associated with this issue.