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
To notify users of the acuson s family ultrasound systems of a recent finding regarding needle guides. two transducers 6c1hd and 18l6 hd demonstrate misalignment while utilizing the on-screen guidelines. the issue occurs when using the civco biopsy attachments in combination with the acuson s family on-screen guidelines. the biopsy needle may traverse outside the on-screen guidelines. this occurs on the 6c1 hd and 18l6 hd transducers.