FDA recall Z-0389-2022

Product

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

Reason for recall

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

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

Key facts

Status

Terminated

Initiation date

2021-08-27

Report date

2021-12-22

Termination date

2026-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Walsall, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0389-2022