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Health Canada Medical devices

CyberKnife Treatment Delivery System

Issued November 22, 2024
Issue
Accuray Incorporated has discovered an issue related to the CyberKnife Standard Treatment Couch (STC). When an internal mechanism becomes disconnected during clinical use, uncontrolled rotation can occur beyond the specified degrees of motion. In rare circumstances snap rings have become partially or completely detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the snap rings are removed or damaged. Recall Start Date: November 15, 2024
Hazard description
Performance
Product
Product name
CyberKnife Treatment Delivery System
Reference
ID
RA-76568