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
Stryker is the distributor of the isoair system. the specification developer/manufacturer of the isoair system has determined that electrical interference emanating from the system may cause clinically unacceptable levels of signal artifact in electrophysiological monitoring devices e.G. ecg ekg or eeg. this only occurs when the active sensor technology (ast) cable from the air pump is connected to the surface. stryker has received a few complaints associated with this issue.