Medical device recalls Moderate risk

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

Recall date
August 27, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0389-2022
FDA classification
Class II
Brand / firm
Xstrahl Limited
Sold / distributed
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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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