FDA-Device2021-12-22Class II
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Xstrahl Limited
Hazard
Base plate may detach from the main body of the treatment applicator.
Sold states
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
Affected count
120 applicators
Manufactured in
Unit 2, Maybrook Industrial Estate Maybro; Maybrook Road, Walsall, United Kingdom
Products
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0389-2022Don't want to check this manually?
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