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
Draeger was informed about a case in which the affected units running vf10.0 software did not generate a set low o2 alarm although the o2 level that was measured by the draeger scio gas measurement module was below the adjusted alarm limit. draeger analysis revealed a failure within the vf10.0 software. earlier software versions are not affected.