Quick Facts at a Glance
- Recall Date
- November 28, 2025
- Hazard Level
- HIGH
- Brand
- RAYSEARCH LABORATORIES AB
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- RAYSEARCH LABORATORIES AB
- Product type
- Radiation Therapy Treatment Planning System
- Model numbers
- UDI: 0735000201076120240508, 0735000201080820241217 GTIN: 07350002010761, 07350002010808 Serial Numbers: 15.1.0.852, 15.2.0.107 Software Revision: RayStation 2024A SP1, RayStation 2024A SP2 Expiration Date: 2030-04-15
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 28, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact RAYSEARCH LABORATORIES AB or your healthcare provider for instructions. Notification method: E-Mail
About This Product
RayStation software assists healthcare providers in planning radiation therapy treatments. It is critical for ensuring accurate radiation dose calculations during patient treatment.
Why This Is Dangerous
The software may incorrectly retain doses for certain Regions of Interest, leading to potentially unsafe treatment plans. This could result in patients receiving inadequate or excessive radiation.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on accurate radiation therapy planning may face increased health risks if the software remains in use. Immediate action is necessary to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check if the software version is either RayStation 2024A SP1 or RayStation 2024A SP2.
- Verify the model number against the recalled models, 15.2.0 and 15.1.3.
- Determine if the software is being used for Regions of Interest without defined contours.
Where to find product info
Software version and model numbers can typically be found in the software's settings or about section.
What timeline to expect
Expect a response regarding refunds or further instructions within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Follow up with the manufacturer via email or phone.
- Consider reporting the issue to the FDA if no response is received.
How to prevent similar issues
- Always verify software versions before using medical devices.
- Stay informed about recalls and safety notices from manufacturers.
Documentation advice
Keep records of all correspondence with the manufacturer, including emails and any receipts or documentation related to the purchase.
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Product Details
The recall affects RayStation models 15.2.0 and 15.1.3, as well as software versions RayStation 2024A SP1 and RayStation 2024A SP2. The software is used for radiation therapy treatment planning. No price information is available.
Key Facts
- Recall date: November 28, 2025
- Report date: January 28, 2026
- Hazard level: High
- No injuries reported
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