BEUDAMED
    FDA Recall Open, Classified

    NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143

    Recall: Z-2409-2024 · Initiated June 24, 2024

    Recall

    Recall Number
    Z-2409-2024
    Event Number
    94876
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    GWF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 24, 2024
    Posted
    July 24, 2024
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143

    Reason

    Potential for false negative response on the NIM Vital Nerve Monitoring System

    Action

    Medtronic Xomed notified consignees on 06/24/2024 via letter. The letter instructed consignees that Medtronic has developed a NIM" Vital software version 1.5.4 to address this issue. Consignees were also instructed to identify affected products within inventory, share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action, and maintain a copy of this letter for your records. The respective Medtronic Representative will contact you to install the new software version 1.5.4 for correction of the impacted product in your possession. Additionally, consignees were asked to complete and return the customer confirmation form enclosed via email to [email protected]. Medtronic Xomed sent consignees a follow up letter with updated information on 08/22/2024. The update provided additional information and instructions to mitigate the risk with affected devices.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.

    Quantity

    7,804 units