BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated February 27, 2023

    Recall

    Recall Number
    Z-1470-2023
    Event Number
    92012
    Firm
    FUJIFILM Healthcare Americas Corporation
    FEI Number
    1000513161
    Product Code
    IZL
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 27, 2023
    Posted
    April 27, 2023
    Address
    81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160

    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.

    Action

    FUJIFILM Healthcare Americas Corporation (Fujifilm) issued Urgent Medical Device Recall letter on 2/27/23 via email to Distributors ad end-Users. Letter states reason for recall, health risk and action to take: A Fujifilm service engineer will contact your facility to arrange a visit to repair your affected unit(s). ACTIONS TO BE TAKEN BY THE CUSTOMER/END-USER 1)Perform an inspection according to the steps outlined below prior to using the product. a. If there are no abnormalities present during the pre-use inspection the product can continue to be used safely. b. Immediately remove the device from use if any abnormalities are observed and report the issueto your Fujifilm service engineer. 2)Coordinate with the Fujifilm service engineer to schedule the correction of your device whencontacted. 3)Please complete and return the Field Action Verification Form attached on page 6 of this communication. Responding with the information requested is essential for ensuring appropriate action is taken. Please contact our field action coordinator, Alicia Martinez, via phone at 973-459-9206 or email at [email protected], if you have any further questions regarding this field action.

    Distribution

    US Nationwide distribution.

    Quantity

    77 units