Z-0389-2022 Class II Terminated
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