Quick Facts at a Glance
- Recall Date
- November 28, 2025
- Hazard Level
- HIGH
- Brand
- RAYSEARCH LABORATORIES AB
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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: 0735000201055620230630, 0735000201072320231213, 0735000201088420250129 GTIN: 07350002010556, 07350002010723, 07350002010884 Serial Numbers: 14.0.0.3338, 15.0.0.430, 15.1.3.10 Software Revisions: RayStation 2023B, RayStation 2024A +1 more
- Sold at
- Multiple Retailers
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 is a radiation therapy treatment planning system used by healthcare providers to calculate and deliver accurate radiation doses to patients. It is crucial for ensuring effective treatment in cancer therapies.
Why This Is Dangerous
The software's failure to accurately invalidate a calculated radiation dose for certain Regions of Interest can lead to improper treatment planning, potentially endangering patient health.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients relying on accurate dosing for radiation therapy, emphasizing the urgency for immediate action to prevent potential health risks.
Practical Guidance
How to identify if yours is affected
- Check if your software version is 14.0.0, 15.0.0, or 15.1.3.
- Verify if your software has been distributed in the recall notice.
- Contact your healthcare provider for confirmation.
Where to find product info
Software versions can typically be found in the application settings or about section of the software.
What timeline to expect
Refund or replacement processing typically takes 4-8 weeks.
If the manufacturer is unresponsive
- Follow up with the manufacturer via email.
- Document all communications for future reference.
- Consider escalating the issue to relevant health authorities if you receive no response.
How to prevent similar issues
- Always verify software updates and recalls regularly.
- Ensure thorough training for healthcare providers on software functionalities.
- Look for software with strong safety records and certifications.
Documentation advice
Keep records of your purchase, any communications regarding the recall, and screenshots of the software version.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall impacts RayStation and RayPlan software versions 14.0.0, 15.0.0, 15.1.3, RayStation 2023B, RayStation 2024A, and RayStation 2024A SP3. The software was distributed to healthcare facilities in the United States and other countries.
Key Facts
- Recall date: November 28, 2025
- Report date: January 28, 2026
- High hazard level
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.