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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For the leica ophthalmic surgical microscope platform proveo 8 a series of intermittent issues which negatively influenced customer satisfaction were identified through customer complaints. the observed issues can lead to unexpected interruptions of the optics carrier focus drive movement intermittent stops of the x-y coupling movement or sporadic failures in the proper on-screen display funtionality of the hdr recording unit. additionally an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated funtionality. this behavior can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.