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 health has identified an issue with the drx-revolution mobile x-ray system that could result in separation of the tube and yoke assembly. carestream found a single device where four screws in the assembly were not applied in the manufacturing process. to date carestream has found only a single system where this failure has occured and considers it unlikely that there are other drx-revolution mobile x-ray systems where this step was missed. there was no injury associated with this failure.