BEUDAMED
    FDA Recall Open, Classified

    Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

    Recall: Z-1884-2024 · Initiated April 11, 2024

    Recall

    Recall Number
    Z-1884-2024
    Event Number
    94441
    Firm
    FUJIFILM Healthcare Americas Corporation
    FEI Number
    1000513161
    Product Code
    IYN
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 11, 2024
    Posted
    May 22, 2024
    Address
    81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160

    Description

    Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

    Reason

    AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).

    Action

    FujiFilm issued Urgent Medical Device Recall Letter via email on 4/11/24. Letter states reason for recall, health risk and action to take: Please complete and return the Field Action Verification Form attached on page 3 of this communication. Responding with the information requested is essential for ensuring appropriate action is taken. Please accept the replacement of AC adapter that is implemented the countermeasure. Please contact our field action coordinator, Kotei Aoki, via email at [email protected], if you have any further questions regarding this field action.

    Distribution

    US Nationwide distribution.

    Quantity

    418 units