Company: Xstrahl Limited
Date of Enforcement Report: 11/3/2021
Class II
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.
Recall Number: Z-0174-2022
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 mistreatment.
RECALLING FIRM/MANUFACTURER
Xstrahl Limited on 4/26/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
25 systems in the U.S.
DISTRIBUTION
U.S. Nationwide and International