Device Recall ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Xray Systems

  • 모델명 / 제조번호(시리얼번호)
    Not associated with specific serial or lot numbers. Model: CVi Toshiba interface Cable, part number 700318-002.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of AR, AZ, FL, and NY and countries of France, Germany, Italy, Japan, and Spain.
  • 제품 설명
    ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and volume which can be instantaneously and continuously varied. Manufactured by: ACIST Medical Systems, Inc., 7905 Fuller Road, Eden Prairie, MN 55344, USA. The ACIST CVi injection system is able to synchronize with certain X-ray imaging systems from Siemens, Toshiba, GE and Philips. || Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Acist Medical Systems, 7905 Fuller Rd, Eden Prairie MN 55344
  • 제조사 모회사 (2017)
  • Source
    USFDA