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.
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The ct system phantom supplied with certain 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 3mm 4mm 5mm 6mm 7mm and 8mm 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 ifu manual. however the pin visibility deteriorates over time usually a few years. this causes the test to become unreliable and inaccurate. to ensure that low contrast is within specification philips is providing instructions as a guideline to a more reliable check of the image noise on the water layer of the system phantom.