BEUDAMED
    FDA Recall 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 · Initiated December 3, 2014

    Recall

    Recall Number
    Z-1022-2015
    Event Number
    70068
    Firm
    INNOKAS MEDICAL OY TARJUSOJANTIE 12 KEMPELE Finland
    FEI Number
    3007615597
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 3, 2014
    Posted
    January 28, 2015
    Terminated
    April 24, 2015

    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.

    Action

    A notification letter was sent to the distributors on 12/3/2014. The letter requests the devices be returned to the manufacturer for repair.

    Distribution

    Distributed in the US and Europe.

    Quantity

    20 units