BEUDAMED
    FDA Enforcement Class II Completed

    COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.

    Recall: Z-2622-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2622-2023
    Event ID
    92852
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 27, 2023
    Initiation Date
    August 1, 2023
    Classification Date
    September 21, 2023
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894, United States

    Description

    COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.

    Reason

    Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.

    Code Info

    STZ22277-006, STZ22277-007, STZ22277-008, STZ22277-009, STZ22277-010, STZ22277-011, STZ22277-012, STZ22277-013, STZ22277-014, STZ22277-015, STZ22277-016, STZ22277-017, STZ22277-018, STZ22277-019, STZ22277-020, STZ22277-021, STZ22277-022, STZ22277-023, STZ22277-024, STZ22277-025, STZ22277-026, STZ22277-027, STZ22277-028, STZ22277-029, STZ22318-001

    Distribution

    US Distribution to states of: AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH, OR, TX, VA, VT, and OUS International distribution to country of: BRAZIL

    Quantity

    24 units