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 recently received reports of a non-diagnostic image on exams when a normal exposure mode (nem) image is taken immediately prior to an extended exposure mode (eem) image with the system in fast preview mode. investigation revealed that the directview version 5.5 and 5.6 console software when used with drx-1 detector version 69 firmware contained a timing issue which could result in a non-diagnostic image.