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
The ct system phantom supplied with the affected scanners has a special pin by which the customer can check the low contrast (lc) detectability for quality assurance. this pin consists of a nylon (aculon) body with six smaller lexan pins of 3 mm 4 mm 5mm 6 mm 7 mm and 8 mm diameters which have contrast difference of approximately 1% from aculon. the lc test is performed by visually inspecting the section and selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the instructions for use (ifu) manual. this manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable. the pin visibility deteriorates over time because of slow water absorption. as the pin visibility deteriorates the test becomes unreliable and inaccurate.