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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In two cases to date a very rare combination of swelling of the battery cell with a ridge on the inside plastic housing of the battery caused a chain reaction allowing energy in the handpiece battery to be released thus destroying the device and causing smoke damage.
Model Catalog: 608532 (Lot serial: 603752BU: 400000 TO 400705); Model Catalog: 613752BU (Lot serial: 603752BU: 400000 TO 400705); Model Catalog: 613735BU (Lot serial: 603752BU: 400000 TO 400705); Model Catalog: 607921BU (Lot serial: 603752BU: 400000 TO 400705); Model Catalog: 607920BU (Lot serial: 603752BU: 400000 TO 400705); Model Catalog: 627300 (Lot serial: 608535:00001 TO 024999); Model Catalog: 613753 (Lot serial: 608535:00001 TO 024999); Model Catalog: 608535 (Lot serial: 608535:00001 TO 024999); Model Catalog: 608532 (Lot serial: 608535:00001 TO 024999); Model Catalog: 613752BU (Lot serial: 608535:00001 TO 024999); Model Catalog: 613735BU (Lot serial: 608535:00001 TO 024999); Model Catalog: 607921BU (Lot serial: 608535:00001 TO 024999); Model Catalog: 607920BU (Lot serial: 608535:00001 TO 024999); Model Catalog: 627300 (Lot serial: 607921BU:FROM 100000 TO 103280); Model Catalog: 613753 (Lot serial: 607921BU:FROM 100000 TO 103280); Model Catalog: 608535 (Lot serial: 607921BU:FROM 100000 TO 103280); Mod