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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Carestream has identified that if the system user interrupts the daily switch off-set refresh detector calibration by switching the active detector from one bucky to another (e.G. table to the wall) and cancels detector calibration within 30 seconds of initiating this process the previous patient image will be displayed on the console with the current patient's name. the likelihood of this issue occurring is improbable and there have not been any reported injuries or misdiagnosis as a result.