BEUDAMED
    FDA Enforcement Class II Ongoing

    FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33

    Recall: Z-1898-2024 · Reported June 5, 2024

    Enforcement

    Recall Number
    Z-1898-2024
    Event ID
    94443
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    FUJIFILM Healthcare Americas Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2024
    Initiation Date
    April 11, 2024
    Classification Date
    May 24, 2024
    Address
    81 Hartwell Ave Ste 300, Lexington, MA, 02421-3160, United States

    Description

    FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33

    Reason

    Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

    Code Info

    UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002

    Distribution

    US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.

    Quantity

    18 units