BEUDAMED
    FDA Recall Open, Classified

    RMU-2000 Automated Chest Compression Device

    Recall: Z-2543-2024 · Initiated July 12, 2024

    Recall

    Recall Number
    Z-2543-2024
    Event Number
    94960
    Firm
    Defibtech, LLC
    FEI Number
    3003521780
    Product Code
    DRM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    July 12, 2024
    Posted
    August 14, 2024
    Address
    741 Boston Post Rd, Suite 201, Guilford, CT, 06437-2714

    Description

    RMU-2000 Automated Chest Compression Device

    Reason

    Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.

    Action

    On July 12, 2024, the firm notified affected users via Urgent Medical Device Safety Removal letters. Affected units (as identified by serial number) should be quarantined by the customer. Defibtech will contact customers to arrange for the return of the product. Customers' devices will be refunded, repaired, or replaced at no cost to them. Customers who have further transferred the device to a downstream account must notify those accounts of this notice or provide Defibtech with the contact information for those sub-accounts. Defibtech Customer Support: 1-877-453-4507, 7:30AM - 6PM Eastern, Monday thru Friday.

    Distribution

    Domestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to Japan

    Quantity

    174 US, 37 OUS