BEUDAMED
    FDA Enforcement Class II Terminated

    The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.

    Recall: Z-1203-2017 · Reported February 22, 2017

    Enforcement

    Recall Number
    Z-1203-2017
    Event ID
    75616
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    February 22, 2017
    Initiation Date
    May 31, 2015
    Classification Date
    February 15, 2017
    Termination Date
    March 13, 2020
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

    The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.

    Reason

    Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.

    Code Info

    Patient Data Module (PDM) V2 model: Serial numbers 10.03.XXXXX

    Distribution

    Distribution was nationwide to medical facilities. There was also military and government distribution.

    Quantity

    341 sites potentially have the affected product versions