BEUDAMED
    FDA Recall 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 · Initiated May 31, 2015

    Recall

    Recall Number
    Z-1203-2017
    Event Number
    75616
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 31, 2015
    Terminated
    March 13, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    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.

    Action

    The recalling firm issued letters via email dated 3/28/2016 and 7/11/2016, or via certified mail if no email address was available. A third letter dated 1/23/2017 was also issued..

    Distribution

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

    Quantity

    341 sites potentially have the affected product versions