BEUDAMED
    FDA Enforcement Class II Ongoing

    X80 RADiant Photoelectric Therapy System

    Recall: Z-1404-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1404-2022
    Event ID
    90231
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Xstrahl Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 27, 2022
    Initiation Date
    April 27, 2022
    Classification Date
    July 19, 2022
    Address
    Unit 2, Maybrook Industrial Estate Maybro; Maybrook Road, Walsall, N/A, N/A, United Kingdom

    Description

    X80 RADiant Photoelectric Therapy System

    Reason

    There is a potential compatibility issue with the systems and replacement treatment applicators.

    Code Info

    Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008

    Distribution

    US Distribution FL, CA, KY

    Quantity

    7 devices; 70 treatment applicators