Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particl...
FDA Device Recall #Z-1126-2013 — Class II — March 19, 2013
Recall Summary
| Recall Number | Z-1126-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 19, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Accuray Incorporated |
| Location | Sunnyvale, CA |
| Product Type | Devices |
| Quantity | 176 units |
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia.
Lot / Code Information
All units of these models.
Other Recalls from Accuray Incorporated
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1023-2025 | Class II | CyberKnife Treatment Delivery System, REF 06600... | Dec 23, 2024 |
| Z-2489-2023 | Class II | Upper roller bracket (part number 1088370) for ... | Aug 3, 2023 |
| Z-1272-2021 | Class II | CyberKnife Treatment Delivery System - Product ... | Feb 26, 2021 |
| Z-0785-2021 | Class II | TomoTherapy Treatment Delivery System with iDMS... | Dec 10, 2020 |
| Z-0784-2021 | Class II | TomoTherapy Treatment System - Product Usage: u... | Dec 10, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.