Quick Facts at a Glance
- Recall Date
- November 28, 2025
- Hazard Level
- HIGH
- Brand
- RAYSEARCH LABORATORIES AB
- Category
- Health & Personal Care
- 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
- Lot Code: UDI: 0735000201077820240625 GTIN: 07350002010778 Serial Numbers: 16.0.0.847 Software Revision: RayStation 2024B Expiration Date: 2029-06-28
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
The RayStation software is used in radiation therapy treatment planning to calculate the optimal dose of radiation for patients. Healthcare providers rely on its accuracy for effective treatment.
Why This Is Dangerous
The software's defect may lead to incorrect dosing, as it fails to invalidate calculations for certain Regions of Interest. This could result in patients receiving either too much or too little radiation.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this software may face significant health risks due to potential incorrect radiation dosing. The urgency to stop using the software is high, impacting treatment schedules and patient safety.
Practical Guidance
How to identify if yours is affected
- Check if your software version is RayStation 2024B or earlier.
- Verify that your model number is 16.0.0.
- Look for notification emails from RaySearch Laboratories AB regarding the recall.
Where to find product info
You can find serial numbers and model numbers typically in the software settings or about page within the application.
What timeline to expect
Expect a timeline of 4-6 weeks for the processing of any refunds or replacements.
If the manufacturer is unresponsive
- Contact RaySearch Laboratories AB again via email.
- Reach out to your healthcare provider for further assistance.
- File a complaint with the FDA if the issue persists.
How to prevent similar issues
- Ensure that any medical software used has up-to-date certifications.
- Regularly check for recalls or updates from manufacturers.
- Consult with healthcare professionals about any known issues with medical devices.
Documentation advice
Keep records of all communication with the manufacturer, including emails and any provided recall instructions.
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Product Details
The recall affects RayStation/RayPlan software, model 16.0.0, version RayStation 2024B. The product is part of the Radiation Therapy Treatment Planning System and has no specific retail information available.
Key Facts
- Recall date: November 28, 2025
- Report date: January 28, 2026
- High risk level due to potential incorrect radiation dosing
- No reported injuries or incidents
- Immediate stop-use recommendation
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