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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원인
The quality system controls in place at the time of manufacture and the records regarding this product were not consistent with quality systems requirements.
Model Catalog: XMAX (Lot serial: MORE THAN 10 CONTACT MFG); Model Catalog: 98-0050 (Lot serial: D31200076201); Model Catalog: 98-0050 (Lot serial: D31200076204); Model Catalog: 98-0050 (Lot serial: D31200076203); Model Catalog: 98-0050 (Lot serial: D31200076202)