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.
데이터 추가 비고
원인
Labelling updates to distributed user manuals instructions for use quick reference guides and instrument release kit for use with da vinci surgical systems and instruments and accessories. updates have been implemented to incorporate user feedback not previously addressed.
Model Catalog: IS3000 (Lot serial: all lots. contact mfg); Model Catalog: IS1200 (Lot serial: all lots. contact mfg); Model Catalog: IS2000 (Lot serial: all lots. contact mfg)