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
Drager medical gmbh has notified steris of the potential for the welded seam in affected monitor spring arms to crack and/or break. the spring arm is a component of the harmony ll 500/700 monitor mountin system. should a break in the welded seam of the spring arm occur there is potential for the monitor mount and monitor to drop down or fall.