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
Investigation determined that the monitor's fixed keys may become inoperative or activate without user interaction due to a contamination present in the fixed key panel material. this is a concern because the worst case scenario of this malfunction could be that the monitor may discharge to a patient automatically.
Model Catalog: MS18597 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: MS18597 (Lot serial: SEE MANUFACTURER.); Model Catalog: MS18852 (Lot serial: 5399664949); Model Catalog: MS18852 (Lot serial: 6000446771); Model Catalog: MS18852 (Lot serial: 5399533850); Model Catalog: MS18852 (Lot serial: 5399532753); Model Catalog: MS18852 (Lot serial: 5399532156); Model Catalog: MS18852 (Lot serial: 5399498745); Model Catalog: MS18852 (Lot serial: 5399494054); Model Catalog: MS18852 (Lot serial: 5399469251); Model Catalog: MS18852 (Lot serial: 5399468849); Model Catalog: MS18852 (Lot serial: 5399463952); Model Catalog: MS18852 (Lot serial: 5399662354); Model Catalog: MS18852 (Lot serial: 6000796170)