BEUDAMED
    FDA Recall Completed

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

    Recall: Z-0839-2025 · Initiated March 14, 2022

    Recall

    Recall Number
    Z-0839-2025
    Event Number
    95913
    Firm
    Augustine Temperature Management, LLC
    FEI Number
    3005857264
    Product Code
    DWJ
    Status
    Completed
    Root Cause
    Device Design
    Initiated
    March 14, 2022
    Posted
    January 10, 2025
    Address
    15305 Minnetonka Blvd, Minnetonka, MN, 55345-1512

    Description

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

    Reason

    HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

    Action

    Augustine Temperature Management, LLC began correcting (installing ferrites and software updates) the affected devices February, 2022 and completed the actions in August 2023. The firm did not perform any notification to its consignees that corrections would be implemented.

    Distribution

    Worldwide

    Quantity

    17 units