Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Concerto User Interface Software provided with the following systems: (1) Recalled by Xstrahl Limited Due to If a saved treatment plan with 2 opposing...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Xstrahl Limited directly.
Affected Products
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.
Quantity: 25 systems in the U.S.
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Xstrahl Limited
Xstrahl Limited has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report