Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Accuray CyberKnife System Medical Physicist Recalled by Accuray Incorporated Due to A defect on the master-side connector block of...
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 Accuray Incorporated directly.
Affected Products
Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
Quantity: 176 units
Why Was This Recalled?
A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Accuray Incorporated
Accuray Incorporated has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report