BEUDAMED
    FDA Enforcement Class II Terminated

    Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system

    Recall: Z-0389-2022 · Reported December 22, 2021

    Enforcement

    Recall Number
    Z-0389-2022
    Event ID
    88545
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Xstrahl Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 22, 2021
    Initiation Date
    August 27, 2021
    Classification Date
    December 16, 2021
    Termination Date
    March 4, 2026
    Address
    Unit 2, Maybrook Industrial Estate Maybro; Maybrook Road, Walsall, N/A, United Kingdom

    Description

    Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system

    Reason

    Base plate may detach from the main body of the treatment applicator.

    Code Info

    GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506

    Distribution

    US and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA, CYPRUS, DENMARK, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KAZAKHSTAN, LATVIA, MALTA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, ROMANIA, RUSSIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UK, UKRAINE

    Quantity

    120 applicators