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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Manufacturer has received complaints of near misdiagnoses caused by artifacts on images.
Model Catalog: 160-5906 (Lot serial: 051CO.); Model Catalog: 812-7334 (Lot serial: ALL LOTS NUMBERS WITH 304CE); Model Catalog: 825-9269 (Lot serial: ALL LOTS NUMBERS WITH 304CE); Model Catalog: 167-8663 (Lot serial: ALL LOTS NUMBERS WITH 304CE); Model Catalog: 810-7823 (Lot serial: 051CO.); Model Catalog: 167-8663 (Lot serial: 051CO.); Model Catalog: 825-9269 (Lot serial: 051CO.); Model Catalog: 812-7334 (Lot serial: 051CO.); Model Catalog: 160-5906 (Lot serial: ALL LOT NUMBERS ENDING WITH); Model Catalog: 810-7823 (Lot serial: ALL LOT NUMBERS ENDING WITH); Model Catalog: 167-8663 (Lot serial: ALL LOT NUMBERS ENDING WITH); Model Catalog: 825-9269 (Lot serial: ALL LOT NUMBERS ENDING WITH); Model Catalog: 812-7334 (Lot serial: ALL LOT NUMBERS ENDING WITH); Model Catalog: 160-5906 (Lot serial: ALL LOT NUMBERS WITH XXXCR); Model Catalog: 810-7823 (Lot serial: ALL LOT NUMBERS WITH XXXCR); Model Catalog: 167-8663 (Lot serial: ALL LOT NUMBERS WITH XXXCR); Model Catalog: 825-9269 (Lot serial: ALL LOT NUMBERS WITH X