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
Siemens is informing customers a possible hazard to patients or operators when moving the ceiling suspension of all axiom aristos fx systems (pn 7414803) with serial numbers up to and including 1168. in the event the 3 wheeled cable cart moves behind the point of the fixed cable holder the corrugated hose may get stuck behind the hose from the fixed cable holder. and in case the cable cart and the corrugated hose cannot move freely the cable cart may get pushed out of the ceiling suspension if it is pulled into the direction of the tube stand. if this occurs there is a potential for the cable holder to drop down. only the cable holders with 3 wheels are affected. cable holders with 4 wheels are not affected by this malfunction.