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 small percentage of the devices (approximately 1%) may deliver less than the intended amount of ultrasound. this reduction in ultrasound output is the result of partial loosening of internal glued components within the small black cylindrical head called a transducer. reduced ultrasound output may affect the progres of patient fracture healing.