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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On powerled 700 the ambient light module is a set of three leds that are intended for an easy viewing of and around operating fields. in some product models this module is attached to the cupola through a set of 4 fixing tabs which compose the plastic enclosure of the ambient light module. there is a potential risk of failure concerning the fixation of the module. one or several fixing tabs may be broken which may lead the ambient light module to detach remaining attached by its wires only. the occurrence rate observed is lower than 1% and is mainly seen in the early use of the devices.