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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The recall relates to a potential problem with the jackscrew and nut assemblies on some panoramic x-ray model pc-1000 units. in some units the jackscrew and nut assemblies may not have been adequately lubricated during assembly which may result in excessive wear and the assemblies may slip. signs of excessive wear may include unusual noise or hesitation or interference with smooth operation while the unit is moving up or down.