BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-2184-2018 · Initiated December 4, 2017

    Recall

    Recall Number
    Z-2184-2018
    Event Number
    80137
    Firm
    Cellavision AB Forskningsbyn Ideon Scheelevagen 19a Lund Sweden
    FEI Number
    3003630693
    Product Code
    JOY
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    December 4, 2017

    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

    Reason

    A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.

    Action

    CellaVision sent an Urgent Medical Device Recall letter dated December 4, 2017. The letter identified affected product, problem and the actions to be taken. Customers are requested to determine if they are affected or not. If affected they are requested to contact their local distributor for installing a patch. Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to their local distributor. For technical questions contact CelleVision ([email protected])

    Distribution

    US Nationwide in the states of FL, IL, NY, and NC

    Quantity

    Instruments: 224 Software: 99 (US)