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
Olympus is conducting a recall of certain serial numbers of tjf-q180v duodenoscopes that were repaired by olympus canada inc. the purpose of this action is to inspect for and correct as necessary a potential quality issue associated with the application of adhesive to the distal end tip during the previous repair work for these tjf-q180v duodenoscopes. this action is limited exclusively to repairs done by olympus canada inc. for specific serial numbers.