Xstrahl Concerto Software Fails to Update Opposing Beam Treatment Parameters
Xstrahl's Concerto software used in X-ray therapy systems may fail to update treatment parameters for a second beam when a treatment plan is edited. This could result in error messages and incorrect treatment delivery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall. Although no injuries have been reported, the software error creates a risk of incorrect radiation therapy delivery, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Xstrahl Limited is recalling the Concerto User Interface Software used with five models of electronic X-ray therapy systems: Xstrahl 100, Xstrahl 150, Xstrahl 200, Xstrahl 300, and Xstrahl X 80. The recall affects software versions V2.0, V2.1, and V2.2 when used with treatment plans involving two opposing therapy beams.
A software error occurs when a saved two-beam treatment plan is edited before approval. When the plan is saved after editing, the second beam fails to update with the new treatment parameters. This results in parameter mismatches that can cause error messages during treatment and potential mis-delivery of therapy.
The FDA identified 25 systems distributed in the United States, located in Arizona, California, Florida, Kentucky, Nevada, Oregon, Pennsylvania, Tennessee, and Texas. Systems also were distributed internationally to Austria, Germany, and Switzerland.
Xstrahl Limited is notifying users directly. Facilities using affected systems should review any two-beam treatment plans edited before approval and verify parameters before treatment delivery. Users should contact Xstrahl Limited for additional guidance on software updates or corrective measures.
The recalled product
- 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 / O
- Manufacturer
- Xstrahl Limited
- Hazard
- treatment-error
- software-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- V2.0
- V2.1
- and V2.2 when 2 opposing beam treatment plans are used.
Distribution
Distributed nationwide across the United States.
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