BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2184-2018
    Event ID
    80137
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cellavision AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 20, 2018
    Initiation Date
    December 4, 2017
    Classification Date
    June 13, 2018
    Address
    Forskningsbyn Ideon, Scheelevagen 19a, Lund, N/A, N/A, Sweden

    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.

    Code Info

    Versions 6.0.1 or 6.0.2

    Distribution

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

    Quantity

    Instruments: 224 Software: 99 (US)