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
Retcam 3 and retcam shuttle devices with v6 software have a software anomaly that causes right eye images to be mislabeled as "left" eye images and or "right" eye images to be mislabeled as "left" eye images when still images are extracted from video recordings. this mislabeling does not occur when an image is captured in still mode. there have been no reported injuries. in the worst case scenario a mislabeled eye image could lead to an error in medical judgement regarding needed intervention.