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
- Lot Code: UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916, 35000201063120220616. GTIN: 07350002010389, 07350002010433, 07350002010440, 07350002010631. Serial Numbers: 11.0.0.951, 11.0.1.29 +5 more
- 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
February 4, 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 designed to assist healthcare providers in calculating radiation doses for patients. It is commonly used in cancer treatment settings to optimize therapy plans.
Why This Is Dangerous
The software contains a defect that may lead to incorrect dose calculations for certain Regions of Interest. This can occur when the ROIs have no contours or have specific material overrides, compromising patient treatment effectiveness.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall poses a serious risk to patient safety, as incorrect radiation doses could lead to ineffective treatment or further complications.
Practical Guidance
How to identify if yours is affected
- Check the software version against the recalled versions: 11.0.0, 11.0.1, 11.0.3, or 11.0.4.
- Verify if your installation includes any Regions of Interest with the mentioned defects.
- Contact your healthcare provider for assistance in verifying if your system is affected.
Where to find product info
Software version information can typically be found in the software settings or about section of the application.
What timeline to expect
Expect a refund processing timeline of approximately 4-6 weeks after submitting your request.
If the manufacturer is unresponsive
- Document all communication attempts with RaySearch Laboratories.
- Consider contacting the FDA to report unresponsiveness.
How to prevent similar issues
- Ensure future software updates include thorough testing for dose calculation accuracy.
- Investigate alternative software solutions with strong safety records before purchase.
- Consult with peers about software reliability before implementation.
Documentation advice
Keep copies of purchase receipts, correspondence with the manufacturer, and any documentation related to the recall for your records.
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Product Details
The recall includes the RayStation software versions 11.0.0, 11.0.1, 11.0.3, and 11.0.4. Model numbers include Lot Code UDI: 0735000201038920210518 and others. The software was distributed before the recall date.
Key Facts
- Recall date: November 28, 2025
- Affected software versions: 11.0.0, 11.0.1, 11.0.3, 11.0.4
- Quantity recalled: 10 units
- High hazard classification
- Immediate action required for healthcare providers
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Safety Guide
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