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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Due to increased efficiency of led manufacture the replacement led boards (part #001840) for the neoblue 2 systems contain leds which have higher intensity than those in the original device. as a result the light intensity may need to be adjusted using the device potentiometer or through treatment distance.