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: 0735000201054920220616, 0735000201067920221007, 0735000201073020230913 GTIN: 07350002010549, 07350002010679, 07350002010730 Serial Numbers: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Revisions: RayStation 12A, 12A SP 1 +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 software system used in radiation therapy treatment planning. It allows healthcare providers to plan and optimize treatment for cancer patients.
Why This Is Dangerous
The software may fail to invalidate certain calculated radiation doses, especially for Regions of Interest lacking contours or having specific material overrides, leading to potential treatment inaccuracies.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers may face delays in treatment planning and need to implement alternative methods while awaiting further instructions.
Practical Guidance
How to identify if yours is affected
- Check the model and software version against the recalled list.
- Verify if your software includes versions 13.0.0.1547, 13.1.0.144, or 13.1.1.89.
- Ensure your software is updated to RayStation 12A, 12A SP1, or 12A SP2.
Where to find product info
Model and software version details can typically be found in the software's settings or about section.
What timeline to expect
Expect a refund or replacement to take approximately 4-8 weeks.
If the manufacturer is unresponsive
- Follow up with RaySearch Laboratories via email.
- Document all communication attempts for your records.
- Consider filing a complaint with regulatory agencies.
How to prevent similar issues
- Ensure software is up to date before use.
- Verify compliance with safety standards for medical devices.
- Consult with manufacturers about product recalls regularly.
Documentation advice
Keep copies of receipts, emails, and any correspondence regarding the recall for your records.
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Product Details
Models affected include RayStation/RayPlan versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89. The software versions include RayStation 12A, RayStation 12A SP1, and RayStation 12A SP2. The products were distributed to various healthcare providers.
Key Facts
- Recall date: November 28, 2025
- Report date: January 28, 2026
- Class II recall
- Quantity recalled: 8 units
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Safety Guide
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