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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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