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Xstrahl Limited recalls Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Recalled December 22, 2021 · FDA recall Z-0389-2022 · Xstrahl
Hazard
Base plate may detach from the main body of the treatment applicator. · FDA Class II
Units
120 applicators
Sold at
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
Description
Base plate may detach from the main body of the treatment applicator.
Product
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Manufacturer(s)
Xstrahl Limited
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →