Use cautionMedical device recall · FDA · Published April 26, 2021
Xstrahl Concerto Software Recall: Risk of Mis-treatment with 2 Opposing Beams
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. Read more at govinfonow.com/recall/62727-xstrahl-concerto-software-recall-risk-of-mis-treatment-with-2.
“Xstrahl Concerto Software Recall: Risk of Mis-treatment with 2 Opposing Beams.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62727-xstrahl-concerto-software-recall-risk-of-mis-treatment-with-2. Based on FDA recall #Z-0174-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0174-2022%22&limit=1).
The FDA announced on April 26, 2021, that Xstrahl Limited is recalling Concerto User Interface Software provided with certain Xstrahl brachytherapy and superficial x-ray therapy systems. The software may fail to update beam parameters correctly, leading to error messages during treatment and possible mis-treatment.
How to tell if you have it
Xstrahl Concerto User Interface Software V2.0, V2.1, and V2.2
Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System
Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System
Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System
Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System
Xstrahl X 80 Photoelectric Therapy System
The hazard
If a saved treatment plan with two opposing beams is edited prior to approval, Beam 2 is not updated with the changed parameters upon selecting save. This results in error messages during the treatment and possible mis-treatment.
Context
GovInfoNow's records show Xstrahl Limited has issued two other recalls since August 27, 2021: a recall of the Xstrahl 150 Treatment Applicator on that date due to a base plate detachment hazard, and a recall of the Xstrahl X80 RADiant Therapy System on April 27, 2022, for compatibility issues with applicators. Other recent recalls of similar products include Elekta MOSAIQ Oncology System Software Recall (May 21, 2026) and Elekta Leksell GammaPlan software recalls (December 12, 2025).
How to tell if you have this one
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.
Brand
Xstrahl
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your Xstrahl system model and the Concerto software version installed.
Contact Xstrahl
Reach out to Xstrahl for guidance on whether your software version is affected and what steps to take.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, KY, NV, OR, PA, TN, and TX. The countries of Austria, Germany, and Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Kentucky, Nevada, Oregon, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0174-2022 (April 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0174-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.