BEUDAMED
    FDA Recall Open, Classified

    NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164

    Recall: Z-1623-2025 · Initiated March 10, 2025

    Recall

    Recall Number
    Z-1623-2025
    Event Number
    96511
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    GWF
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    March 10, 2025
    Posted
    April 18, 2025
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164

    Reason

    Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

    Action

    On 3/10/2025, recall notices were mailed, and/or emailed to customers who were asked to do the following: 1) Your Medtronic representative will contact you to install the new software version 1.7.5 for correction of the impacted product in your possession. 2) For patients who are currently being monitored with affected devices, be aware of the possibility of increased stimulus artifact. Refer to the system instructions for use for instructions on how the stimulus artifact may be reduced or exacerbated through the adjustment of system settings including event threshold, stimulation current, and rejection period. 3) Complete and return the customer confirmation form via email to [email protected] 4) 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. Maintain a copy of this letter for your records. Distributors are asked to discard any of the items below in your inventory: a. SOFTWARE NIM4SWU143 UPGRADE v1.4.3 b. SOFTWARE NIM4SWU154 UPGRADE v1.5.4 c. SOFTWARE NIM4SWU164 UPGRADE v1.6.4 If you have any questions regarding this communication, please contact the firm's Sales Representative or Technical Services at 1-888-826-5603.

    Distribution

    Worldwide - US Nationwide distribution including in the states of MD, MN, PA, OK, OH, FL, CO, GA, NC, KS, IL, WY, AK, NE, VA, MI, CA, NY, WI, UT, AZ, AR, TX, WA, AL, NJ, SD, MS, KY, TN, MO, OR, MT, MA, CT, NM, LA, WV, NH, DC, DE, IN, NV, IA, SC, ID, ME, HI, RI, VT, ND, GU, PR 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, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Namibia, Nepal, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.

    Quantity

    9,788