Device Recall CellaVision DM96, DM1200, DM9600 and DI60

  • Model / Serial
    Versions 6.0.1 or 6.0.2
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of FL, IL, NY, and NC
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Cellavision AB, Forskningsbyn Ideon, Scheelevagen 19a, Lund Sweden
  • Manufacturer Parent Company (2017)
  • Source
    USFDA