BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2707-2017 · Initiated March 10, 2016

    Recall

    Recall Number
    Z-2707-2017
    Event Number
    77086
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 10, 2016
    Terminated
    March 6, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

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

    Reason

    If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which provides the analog output.

    Action

    The recalling firm issued recall letters dated 3/10/2016, 5/3/2016, and 8/5/2016 via email or via certified mail if the email address is not available.

    Distribution

    Distribution US nationwide.

    Quantity

    555 PDM's