Accuray Incorporated recalls CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Rob…

Recall date

December 23, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1023-2025

FDA classification

Class II

Brand / firm

Accuray Incorporated

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.