Xstrahl recalls Concerto software versions V2.0-V2.2 for Xstrahl 100-300 systems. Editing treatment plans with 2 opposing beams before approval can cause mis-treatment errors. Affected users should contact Xstrahl for guidance.
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.
Xstrahl is recalling specific versions of its Concerto User Interface Software for certain radiation therapy systems. If users edit a treatment plan with two opposing beams before approval, the software may not update Beam 2 correctly, leading to potential mis-treatment during radiation therapy.
The software error occurs when a treatment plan with two opposing beams is edited before approval. Saving the plan without updating Beam 2's parameters can cause error messages during treatment and potentially mis-treat the patient.
Medical professionals using Xstrahl 100, 150, 200-225kV, 300kV, or X80 systems with Concerto software versions V2.0-V2.2 are most at risk. These systems are used for superficial X-ray therapy in radiation treatment.
Check if your Xstrahl system (100, 150, 200-225kV, 300kV, or X80) has Concerto software versions V2.0, V2.1, or V2.2. The software is included with these systems for radiation therapy.
Identify your Xstrahl system model and the Concerto software version installed.
Reach out to Xstrahl for guidance on whether your software version is affected and what steps to take.
The software error can cause mis-treatment if a plan with two opposing beams is edited before approval, but it does not cause immediate harm. Affected users should follow the recall steps.
Systems include Xstrahl 100, 150, 200-225kV, 300kV, and X80 with Concerto software versions V2.0, V2.1, or V2.2.
No immediate stop is required, but users should check their software version and contact Xstrahl for specific guidance.
We’ve drafted a message you can send Xstrahl to request your refund or repair — edit it as you like.
Subject: Recall Z-0174-2022 — Xstrahl Xstrahl Hello, I own a Xstrahl that is covered by recall Z-0174-2022 from Xstrahl. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
