BEUDAMED
    FDA Enforcement Class II Ongoing

    FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

    Recall: Z-1299-2026 · Reported February 11, 2026

    Enforcement

    Recall Number
    Z-1299-2026
    Event ID
    98124
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    FUJIFILM Healthcare Americas Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2026
    Initiation Date
    January 9, 2026
    Classification Date
    February 5, 2026
    Address
    81 Hartwell Ave Ste 300, N/A, Lexington, MA, 02421-3160, United States

    Description

    FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

    Reason

    It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.

    Code Info

    Model Number: CH-200; (1) Version: 566-16130-23; UDI-DI: 04540217052226; Serial numbers: MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001; (2) Version: 566-16130-31; UDI-DI: 04540217057436; Serial numbers: MP95AA783001; (3) Version: 566-16130-33; UDI-DI: 04540217057450; Serial numbers: MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002;

    Distribution

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

    Quantity

    16 units