U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
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 data.
데이터 추가 비고
Contrast Media Injection System - Product Code CXT
원인
The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. the injector will always inject in accordance with the parameters shown on the power head. if this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than desired.
조치
The recalling firm sent a letter dated 11/7/2006 to all consignees.
Worldwide distribution ---- including USA and countries of Australia, Belgium, Brazil, Canada, Chile, Columbia, Denmark, Mexico, Panama, Puerto Rico, Singapore and South Africa.