BEUDAMED
    FDA Recall Open, Classified

    MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4

    Recall: Z-0231-2026 · Initiated August 22, 2025

    Recall

    Recall Number
    Z-0231-2026
    Event Number
    97564
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    DPS
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    August 22, 2025
    Posted
    October 22, 2025
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4

    Reason

    If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

    Action

    An "URGENT MEDICAL DEVICE CORRECTION" notification letter dated 8/22/25 was sent to customers. Actions to be taken by Customer/User: You can continue to use your device in accordance with the instructions in the MAC VU360 Operator Manual and the actions described below: 1. Inspect all potentially affected devices for the presence of damage to the Acquisition Trunk Cable per the MAC VU360 Operator Manual (P/N 2088531-202, Section 11). 2. If the Acquisition Trunk Cable shows damage, remove the cable from service. 3. Ensure the Acquisition Module is placed correctly in the Acquisition Module Holder and that the Acquisition Trunk Cable is not pinched during insertion. See section 1.3 of the MAC VU360 V1.03 Setup and Configuration Manual (P/N 2088531-204). Note: Manuals can be accessed from the GE HealthCare Customer Documentation Portal at https://www.gehealthcare.com/support/manuals 4.Please complete and return the attached acknowledgement form to [email protected] GE HealthCare will provide a customer-installable kit containing a new Acquisition Trunk Cable and a redesigned Acquisition Module Holder for the affected devices at no cost to you. Please make sure all potential users in your facility are made aware of this safety notification and the recommended actions. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide Distribution: US (nationwide) and OUS (foreign/Global) to countries of: Australia, Austria, Bahrain, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, Sweden, Switzerland, Thailand, United Arab Emirates, and United Kingdom.

    Quantity

    29,225 units