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: 0735000201031020201216. GTIN: 07350002010310. Serial Numbers: 10.1.0.613. Software Revision: RayStation 10B. Expiration Date: 2027-02-01.
- 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
The RayStation/RayPlan software is used in radiation therapy treatment planning, helping healthcare providers calculate radiation doses for patients. Its accuracy is critical for safe and effective treatment.
Why This Is Dangerous
The software may fail to invalidate radiation doses correctly when certain conditions are met, which could lead to dangerous treatment errors. This defect particularly affects ROIs with no contours or specific material overrides.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare providers and patients face significant safety risks due to potential inaccuracies in treatment planning, which could lead to improper radiation exposure.
Practical Guidance
How to identify if yours is affected
- Verify your software version is RayStation/RayPlan 10B with model number 10.1.
- Confirm that ROIs in use meet the conditions described in the recall.
Where to find product info
You can find the software version and model number in the software settings or installation documentation.
What timeline to expect
Expect a response from the manufacturer within 4-6 weeks regarding the recall and any potential fixes.
If the manufacturer is unresponsive
- Contact RAYSEARCH LABORATORIES AB via email.
- Report the issue to the FDA if you do not receive a response.
How to prevent similar issues
- Always check for software updates and recalls regularly.
- Ensure thorough verification of treatment planning systems before use.
- Consult with peers and industry updates for safety practices.
Documentation advice
Keep records of all correspondence regarding the recall, including emails and any instructions received.
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Product Details
The recall affects RayStation/RayPlan software version 10B, model number 10.1, and UDI: 0735000201031020201216. The product was distributed to healthcare providers but specific retailers are not listed.
Key Facts
- Software version 10B affected
- Stop using immediately
- Contact manufacturer for instructions
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Safety Guide
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