Recall Z-0389-2022— Xstrahl Limited

Name: FDA recall Z-0389-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-27

Class II · Terminated

Class II FDA medical device recall by Xstrahl Limited, initiated 2021-08-27, terminated 2026-03-04. It names one FDA 510(k) clearance: K962613. Product: Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system. Reason: Base plate may detach from the main body of the treatment applicator..

Recalling firm: Xstrahl Limited
Classification: Class II
Status: Terminated
Initiated: 2021-08-27
Terminated: 2026-03-04
Firm location: Walsall, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K962613 — DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEMGulmay Medical , Ltd.·cleared 1996-09-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.