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
Coopersurgical recently completed validation of a new disinfection procedure and the instructions for use (ifu) for the affected products have been updated. copies of the updated ifu are being sent to end users. additionally coopersurgical has determined that the useful life of the affected products is 5 years based on a 650 maximum reprocessing cycles.
Model Catalog: 50502 (Lot serial: All lots); Model Catalog: 50501 (Lot serial: All lots); Model Catalog: 2400 (Lot serial: All lots); Model Catalog: 2402 (Lot serial: All lots); Model Catalog: 2401 (Lot serial: All lots)
제품 설명
Cryosurgery System LM-900;Frigitronics Cryo-Plus Cryosurgery System