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: 0735000201082220250423, 0735000201094520250702 GTIN: 07350002010822, 07350002010945 Serial Numbers: 17.0.0.1270, 17.0.1.113 Software Revision: RayStation v2025, RayStation v2025 SP1 Expiration Date: 2030-10-22
- 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 in healthcare settings for planning radiation doses. It aids healthcare providers in delivering precise therapeutic doses to patients.
Why This Is Dangerous
The software's failure to invalidate dose calculations for certain ROIs can lead to incorrect treatment plans, potentially affecting patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this software for radiation therapy may face significant safety risks due to potential dose calculation errors.
Practical Guidance
How to identify if yours is affected
- Check the software version in your system settings.
- Verify if you are using RayStation version 17.0.0 or 17.0.1.
- Look for notifications or emails from RAYSEARCH LABORATORIES AB regarding the recall.
Where to find product info
Software version information can typically be found in the settings or about section of the application.
What timeline to expect
Expect to receive instructions from RAYSEARCH LABORATORIES AB within a few days after reporting the recall.
If the manufacturer is unresponsive
- Contact RAYSEARCH LABORATORIES AB again for follow-up.
- Check for updates on the FDA website regarding the recall.
How to prevent similar issues
- Verify software updates regularly to ensure you are using the latest version.
- Consider alternative radiation planning software as a backup.
Documentation advice
Keep records of any correspondence with the manufacturer and document the software version you are using.
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Product Details
The recall affects RayStation/RayPlan software versions 17.0.0 and 17.0.1, specifically RayStation v2025 and RayStation v2025 SP1. The affected products are distributed under Lot Code: UDI: 0735000201082220250423 and 0735000201094520250702.
Key Facts
- Recall date: November 28, 2025
- Hazard level: High
- No reported incidents or injuries
- Affected software versions: RayStation v2025, v2025 SP1
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