Accuray CyberKnife Treatment Delivery System Recall 2026

Health Canada has issued a Type II recall for the CyberKnife® Treatment Delivery System, manufactured by Accuray, Inc., due to a performance issue that could interrupt radiation treatment procedures and pose risks to patients. The recall, identified under reference number RA-82239, covers four specific lot numbers under model catalogue number 0660000 and is directed at healthcare facilities operating this robotic radiosurgery equipment.

What Products Are Being Recalled?

The following units of the CyberKnife® Treatment Delivery System (Model/Catalogue No. 0660000) are affected by this recall:

• Lot C0417 — CyberKnife® Treatment Delivery System
• Lot C0545 — CyberKnife® Treatment Delivery System
• Lot C0573 — CyberKnife® Treatment Delivery System
• Lot C0351 — CyberKnife® Treatment Delivery System

All affected units fall under the health product category of Medical Devices — Radiology and are used in clinical settings to deliver precise radiation therapy to tumors and other medical conditions requiring radiosurgery.

Why Was This Recall Issued?

The recall was initiated due to a confirmed performance defect involving the collimator housing exchange process. Specifically, during the drop-off or pickup of the collimator housing over the Xchange® table, the CyberKnife® system may unexpectedly interlock, causing it to stop all motion and prompt the operator to contact service personnel.

This malfunction occurs during an active phase of the treatment setup, which means a patient may be present on the treatment table when the system fails. An unexpected stoppage during treatment delivery could disrupt radiation therapy sessions, delay critical patient care, and require immediate manual intervention by trained clinical staff. The unpredictability of the interlock event raises significant concerns about patient safety and the continuity of care in radiation oncology departments.

Who Is Affected?

This recall is directed exclusively at the healthcare audience — specifically hospitals, cancer treatment centres, and radiosurgery clinics in Canada that operate the CyberKnife® Treatment Delivery System under the affected lot numbers. Patients undergoing radiosurgical treatments at facilities using these specific units may be indirectly affected if their therapy sessions are interrupted due to the performance issue. Individual consumers do not purchase or operate this device.

What Should You Do?

• Healthcare facilities should immediately identify whether they possess any of the recalled lot numbers: C0417, C0545, C0573, or C0351.
• If a system interlock occurs during collimator housing drop-off or pickup over the Xchange® table, remove the patient from the treatment area before beginning any troubleshooting.
• Do not attempt to move the treatment robot using the in-room pendant during a malfunction event.
• Contact Accuray service immediately for technical support and guidance on restoring system functionality.
• For additional information regarding the recall or affected units, contact the manufacturer, Accuray, Inc., directly.
• Report any adverse events or device malfunctions to Health Canada as required under applicable medical device regulations.

Official Statement

According to Health Canada, the recall is classified as a Type II health product recall, indicating that use of the affected device may cause temporary adverse health consequences, or that the probability of serious adverse health consequences is remote. The recall was originally initiated on 2026-06-11 and published on 2026-06-22. Accuray, Inc. is headquartered at 1209 Deming Way, Madison, Wisconsin, United States. Healthcare professionals and facility administrators are urged to act promptly upon receipt of this notice and to contact Accuray service for further instructions and corrective actions.