Recall – Incorrect treatment plan error messages

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.