RayStation software version 4.0.3.4 RayStation is a software system designed for treatment pla...
FDA Device Recall #Z-1806-2014 — Class II — April 25, 2014
Recall Summary
| Recall Number | Z-1806-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 25, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | RAYSEARCH LABORATORIES AB |
| Location | Stockholm, N/A |
| Product Type | Devices |
| Quantity | 25 sites/245 units (US), 25 sites/124 units (foreign) |
Product Description
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Reason for Recall
This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.
Lot / Code Information
Software version 4.0.3.4
Other Recalls from RAYSEARCH LABORATORIES AB
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1110-2026 | Class II | Brand Name: RayStation Product Name: RayStatio... | Nov 28, 2025 |
| Z-1106-2026 | Class II | Brand Name: RayStation Product Name: RayStatio... | Nov 28, 2025 |
| Z-1109-2026 | Class II | Brand Name: RayStation Product Name: RayStatio... | Nov 28, 2025 |
| Z-1104-2026 | Class II | RayStation/RayPlan. Model/Catalog Numbers: 12.0... | Nov 28, 2025 |
| Z-1108-2026 | Class II | Brand Name: RayStation Product Name: RayStatio... | Nov 28, 2025 |
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.