BEUDAMED
    FDA Enforcement Class II 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 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2707-2017
    Event ID
    77086
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 19, 2017
    Initiation Date
    March 10, 2016
    Classification Date
    July 10, 2017
    Termination Date
    March 6, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    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.

    Code Info

    All Schiller PB-1000 PDM's distributed on or before 8/11/2016.

    Distribution

    Distribution US nationwide.

    Quantity

    555 PDM's