Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate Cy...
FDA Device Recall #Z-3211-2018 — Class II — August 31, 2018
Recall Summary
| Recall Number | Z-3211-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 31, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Accuray Incorporated |
| Location | Madison, WI |
| Product Type | Devices |
| Quantity | 259 units |
Product Description
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Reason for Recall
the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System
Distribution Pattern
Worldwide Distribution: United States (nationwide), and countries of: United Kingdom, Germany, France, Finland, Netherlands, Portugal, Hong Kong, Poland, Australia, United Arab Emirates, Thailand, and Japan.
Lot / Code Information
All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018
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-0784-2021 | Class II | TomoTherapy Treatment System - Product Usage: u... | Dec 10, 2020 |
| Z-0785-2021 | Class II | TomoTherapy Treatment Delivery System with iDMS... | 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.