BEUDAMED
    FDA Recall Terminated

    Merge Cardio with software version 10.1 LA.

    Recall: Z-0555-2016 · Initiated October 26, 2015

    Recall

    Recall Number
    Z-0555-2016
    Event Number
    72661
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 26, 2015
    Terminated
    July 22, 2016
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge Cardio with software version 10.1 LA.

    Reason

    The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.

    Action

    Consignees were either contacted via phone 9/2015 or in person 7/31/2015. The customer communications involved the need to upgrade the consignees software. Merge Healthcare did not script the conversations because they opted to hold one-on-one management level discussions to carefully explain the importance of moving to the Generally Available (GA) release.

    Distribution

    Distributed in the states of IL, NC, and VT.

    Quantity

    1