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
Carestream has identified an issue related to the drx-revolution mobile x-ray system where the boom arm can become loose. it has been determined that this issue is a result of an improperly assembled part which holds the x-ray tube assembly/boom to the device mounting block at the top of the column.