Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Recalled by Varian Medical Systems Due to Reports have been received of an anomaly that...
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 Varian Medical Systems directly.
Affected Products
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Quantity: 387
Why Was This Recalled?
Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Varian Medical Systems
Varian Medical Systems 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