Recall Z-0174-2022— Xstrahl Limited

Name: FDA recall Z-0174-2022
Creator: U.S. Food and Drug Administration
Published: 2021-04-26

Class II · Terminated

Class II FDA medical device recall by Xstrahl Limited, initiated 2021-04-26, terminated 2024-01-26. It names 2 FDA 510(k) clearances: K172080, K962613. Product: Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System; (5) Xstrahl X 80 Photoelectric Therapy System.. Reason: If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible mis-treatment..

Recalling firm: Xstrahl Limited
Classification: Class II
Status: Terminated
Initiated: 2021-04-26
Terminated: 2024-01-26
Firm location: Walsall, N/A, United Kingdom

510(k) clearances named in this recall

2 on FDA's record

K172080 — Photoelectric Therapy SystemXstrahl, Ltd.·cleared 2017-09-29
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

Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System; (5) Xstrahl X 80 Photoelectric Therapy System.

Reason for recall

If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible mis-treatment.

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