BEUDAMED
    FDA Enforcement Class II Ongoing

    FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams

    Recall: Z-1470-2023 · Reported May 3, 2023

    Enforcement

    Recall Number
    Z-1470-2023
    Event ID
    92012
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    FUJIFILM Healthcare Americas Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 3, 2023
    Initiation Date
    February 27, 2023
    Classification Date
    April 27, 2023
    Address
    81 Hartwell Ave Ste 300, N/A, Lexington, MA, 02421-3160, United States

    Description

    FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams

    Reason

    Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.

    Code Info

    UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.

    Distribution

    US Nationwide distribution.

    Quantity

    77 units