# FDA recall Z-0389-2022

> **Xstrahl  Limited** · Class II · device recall initiated 2021-08-27.

## 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

- **Recall number:** Z-0389-2022
- **Recalling firm:** Xstrahl  Limited
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0389-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0389-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*