BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)

    Recall: Z-1967-2025 · Initiated November 1, 2023

    Recall

    Recall Number
    Z-1967-2025
    Event Number
    96873
    Firm
    Turncare, Inc
    FEI Number
    3013682457
    Product Code
    FNM
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    November 1, 2023
    Posted
    June 12, 2025
    Address
    230 W Parkway, Ste 6, Pompton Plains, NJ, 07444-1060

    Description

    Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)

    Reason

    A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

    Action

    Between June 2023 and November 2023 software updates to resolve the issue were performed by TurnCare on affected units. The software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy. Successful update of the software was verified on each affected controller.

    Distribution

    US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut

    Quantity

    1081 units