RayStation Product Usage: is a software system designed for treatment planning and analysis ...
FDA Device Recall #Z-0380-2018 — Class II — July 17, 2017
Recall Summary
| Recall Number | Z-0380-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 17, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | RAYSEARCH LABORATORIES AB |
| Location | Stockholm, N/A |
| Product Type | Devices |
| Quantity | 117 units |
Product Description
RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
Reason for Recall
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
Distribution Pattern
US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
Lot / Code Information
6.0.0.24 , 6.1.0.26 , 6.1.1.2 or 6.2.0.7
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.