Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system d...

FDA Device Recall #Z-0720-2017 — Class II — October 11, 2016

Recall Summary

Recall Number Z-0720-2017
Classification Class II — Moderate risk
Date Initiated October 11, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm RAYSEARCH LABORATORIES AB
Location Stockholm, N/A
Product Type Devices
Quantity 540 units

Product Description

Radiation Therapy Treatment Planning System Product Usage: 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 may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. When the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing.

Distribution Pattern

US Nationwide Distribution in the states of AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, MA, MD, MN, MI, MS, MO, NJ, NY, NC, OH, PA, RI, TX & WA

Lot / Code Information

Build No: "5.0.0.37, 5.0.1.11 or 5.0.2.35. Only 5.0.2.35 was distributed in the U.S.

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.