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 an issue at a customer site related to the dr 7500 beta assembly (x-ray tube and collimator) detaching from the overhead tube crane (otc) telescope. it has been determined that as a result of an impromperly assembled part which holds the beta assembly to the otc telescope an inspection of the part is needed and in addition a repair of the assembly may be required.