BEUDAMED
    FDA Recall Open, Classified

    NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

    Recall: Z-1223-2022 · Initiated May 3, 2022

    Recall

    Recall Number
    Z-1223-2022
    Event Number
    90163
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    GWF
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    May 3, 2022
    Posted
    June 2, 2022
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

    Reason

    Software anomaly was identified.

    Action

    The firm issued a recall notification to consignees on 05/03/2022 via mail. The letter instructs the consignee to follow the IFU regarding the setup and "Lead Off Detected" error message, forward the notification to those who need to be aware within the organization and to any location which the devices have been distributed, and to complete the response form. An additional correction notification was sent on about 09/13/2023 to notify consignees of the update availability (NIM Vital" SW version v1.4.3) to fix this issue.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.

    Quantity

    18 units