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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A resistor (r46) could be missing on an unknown quantity of cpu pcb used within the smoothbeam laser system. could lead to the failure of the cryogen delivery system to detect the absence of cryogen during las.
Model Catalog: (Lot serial: 13 SERIAL # ABOVE 9914-0820...); Model Catalog: (Lot serial: 394/434/451/503/510); Model Catalog: (Lot serial: -259/311/323/324/327/332/356); Model Catalog: (Lot serial: 9914-0820-208)