Device Recall CellaVision DM96, DM1200, DM9600 and DI60

  • 모델명 / 제조번호(시리얼번호)
    Versions 6.0.1 or 6.0.2
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide in the states of FL, IL, NY, and NC
  • 제품 설명
    CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 || Product Usage: || The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Cellavision AB, Forskningsbyn Ideon, Scheelevagen 19a, Lund Sweden
  • 제조사 모회사 (2017)
  • Source
    USFDA