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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1-when p3t cardiac protocols are programmed with saline test inject and used in conjunction with isi 700 or isi 800 products and the stellant ct injection system the pre-diagnostic protocol must include a transit bolus. 2-a defect in sw version 103.0 and 104.0 of the stellant ct injection systems may cause isi 700 accessory to incorrectly trigger bolus tracking on a philips ct system for p3t cardiac protocol.