Z-0389-2022 Class II Terminated
FDA device recall Z-0389-2022 was initiated by Xstrahl Limited on August 27, 2021 and is designated Class II. Reason for recall: Base plate may detach from the main body of the treatment applicator. The recall status is terminated (terminated March 4, 2026). Affected quantity: 120 applicators.
Recall Details
- Product Type
- Devices
- Report Date
- December 22, 2021
- Initiation Date
- August 27, 2021
- Termination Date
- March 4, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 applicators
Product Description
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Reason for Recall
Base plate may detach from the main body of the treatment applicator.
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
Code Information
GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506