Radiation Therapy Treatment Planning System software RayStation is a software system designed ...
FDA Device Recall #Z-2785-2015 — Class II — May 29, 2015
Recall Summary
| Recall Number | Z-2785-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 29, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | RAYSEARCH LABORATORIES AB |
| Location | Stockholm |
| Product Type | Devices |
| Quantity | 20 devices |
Product Description
Radiation Therapy Treatment Planning System software RayStation 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
An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
Distribution Pattern
Worldwide Distribution: US (nationwide) to state of WA; and countries of: France, Sweden, Austria, Spain, Germany, Italy, UK, New Zealand.
Lot / Code Information
software build numbers are 4.7.0.15 or 4.7.1.10
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.