Device product
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Z-0389-2022
Product summary
- Firm
- Xstrahl Limited
- Event
- Event 88545
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 applicators
- Official record key
device-enforcement:Z-0389-2022
Official wording
Reason: Base plate may detach from the main body of the treatment applicator.
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
Derived failure modes
-
Unknown
Base plate may detach from the main body of the treatment applicator.