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.
데이터 추가 비고
원인
1. during reliability testing it was determined that the u-arm could move down uncontrolled possibly from the breaking of a steel rope. 2. the screws for the sid chain wheel could be loose which could cause the detector carriage and/or the tube carriage to move down uncontrolled. 3. during in-house testing it was detected that the lifetime of the wire rope is significantly lower than the specified 10 years.