Xstrahl Limited: Medical Device Recall in 2021 - (Recall #: Z-0389-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 27, 2021

Date Posted: December 22, 2021

Recall Number: Z-0389-2022

Event ID: 88545

Reason for Recall:

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

Status: Terminated

Product Quantity: 120 applicators

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated