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
This correction decision has been made because of a potential failure of the top plate which is the component that connects the seating system of the wheelchair to the base. a complete failure of the top plate assembly would result in the chair user and the seating system falling from the base leading to a potential injury. out of 71 cases reported to the fda 3 serious injuries occurred (2 broken bones/1 laceration).
Model Catalog: C500 BASE ONLY (Lot serial: > 10 numbers contact mfg.); Model Catalog: C500 CORPUS II LR (Lot serial: > 10 numbers contact mfg.); Model Catalog: C500 CORPUS II (Lot serial: > 10 numbers contact mfg.); Model Catalog: C400 CORPUS II LR (Lot serial: > 10 numbers contact mfg.); Model Catalog: C400 CORPUS II (Lot serial: > 10 numbers contact mfg.); Model Catalog: C300 CORPUS II (Lot serial: > 10 numbers contact mfg.); Model Catalog: C350 CORPUS II (Lot serial: > 10 numbers contact mfg.); Model Catalog: C300 BASE ONLY (Lot serial: > 10 numbers contact mfg.)