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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A single digital encoder cable assembly during inspection had a loose wire further investigation revealed a deviation in the height of a wire crimp could lead to a loose wire.
Model Catalog: 816570 (Lot serial: 5950 TO 5953); Model Catalog: 816570 (Lot serial: 6621 TO 6640); Model Catalog: 816571 (Lot serial: 6621 TO 6640); Model Catalog: 816571 (Lot serial: 5950 TO 5953)