BEUDAMED
    FDA Enforcement Class II Terminated

    VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.

    Recall: Z-1022-2015 · Reported February 4, 2015

    Enforcement

    Recall Number
    Z-1022-2015
    Event ID
    70068
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    INNOKAS MEDICAL OY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2015
    Initiation Date
    December 3, 2014
    Classification Date
    January 28, 2015
    Termination Date
    April 24, 2015
    Address
    TARJUSOJANTIE 12, N/A, KEMPELE, N/A, N/A, Finland

    Description

    VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.

    Reason

    If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.

    Code Info

    SK514470022YA, SK514470023YA, SK514470024YA, SK514470020YA, SK514470021YA, SK514100003YA, SK514470019YA, SK514470001YA, SK514470017YA, SK514470018YA, SK514450021YA, SK514450022YA, SK514450019YA, SK514470004YA, SK514470005YA, SK514390001YA, SK514150002YA, SK514150004YA, SK514150005YA, SK514300002YA

    Distribution

    Distributed in the US and Europe.

    Quantity

    20 units