medical Class II Updated 2021-12-22

Xstrahl Limited recalls Treatment applicator for Gulmay Medical 150 or Xstrahl 150 s

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

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
Lot/Code Info: GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506
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