BEUDAMED
    FDA Recall Terminated

    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.

    Recall: Z-1923-2017 · Initiated March 30, 2015

    Recall

    Recall Number
    Z-1923-2017
    Event Number
    76946
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    March 30, 2015
    Posted
    May 2, 2017
    Terminated
    May 5, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.

    Reason

    The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification.

    Action

    The recall was initiated by telephone on March 30, 2015. Follow-up phone calls were made July 6, 2015. The firm was unable to provide a telephone script. The recalling firm also issued letters dated March 28, 2016, via email on April 6, 2016, dated July 11, 2016. The letters contained the same content, notified the customer of the issue, and informed them a fix was available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they have the affected ISA CO2 sensors at their facility and are they interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. For further questions, please call (877) 741-5369.

    Distribution

    US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT. There was government distribution and no foreign/military distribution.

    Quantity

    23 sensors (PhaseIn Units)