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
There are 2 parts to this field correction. the avanta fluid management injection system operation manual and operational manual cd contain innacurate saline flow rate specifications. medrad has also received reports of reduced or no saline flow during purging of the avanta system disposables.
Model Catalog: (Lot serial: 20208); Model Catalog: (Lot serial: 20191); Model Catalog: (Lot serial: 20051); Model Catalog: (Lot serial: 20550); Model Catalog: (Lot serial: 20575); Model Catalog: (Lot serial: 20465); Model Catalog: (Lot serial: 20458); Model Catalog: (Lot serial: 20071)
제품 설명
Avanta Fluid Injection System - Main unit with pedestal