Device Recall Radiance Flex Blood Gas Anayzer

  • 모델명 / 제조번호(시리얼번호)
    Catalog Numbers: 914-418 and 914-426
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide-The six USA units (equpped with Radiance software) were distributed to a total of two (2) U.S. customers: University of Missouri Hospitals and Clinics in Columbia, MO (4 units) and Vail Valley Medical Center, Vail, CO (2 units). World wide accounts pending submission. Three (3) Canadian customers. They are: 1) Seven Oaks General Hospital MB Canada; and 2) St. Mary''s General Hospital, 911 Queens Blvd, Ontario Canada; and 3) University of Alberta Hospital, 84440 112th Street, Alberta, Canada.
  • 제품 설명
    Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA