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 was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Injector And Syringe, Angiographic - Product Code DXT
원인
The heat maintainer, an accessory, may overheat and deform the disposable syringe.
조치
The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/12/05 via certified mail. The notice provided instructions to apply warning labels and disconnect the heat maintainer until a field upgrade kit is available. In case where the heat maintainer is a necessity for specific procedures, the customer is being instructed to observe certain precautions.
The products were shipped to medical facilities nationwide. The products were also shipped to Canada, Isreal, Italy, Denmark, Netherlands, Norway, Great Britain, France, Poland, Germany, Spain, Finland, Belgium, Sweden, Russia, Austraila, Cuba, Mexico, Peru, Hong Kong, Korea, Mylasia, Thialand, Taiwan, Singapore, India, China, Turkey, Saudia Arabia, and Japan
제품 설명
Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX