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
Philips has become aware that the hexad 12-lead ecg monitoring derivation uses a 6-lead set and derives remaining leads to provide a non-diagnostic 12-lead view including ecg waves and st measurements. the st elevation alarm on the patient monitor or standalone x2 measurement module will not sound when indicated for all chest leads derived using hexad 12-lead ecg monitoring in the host monitor configuration below: st analysis: "off" ste: "on" ste alarms: "on".