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
- UDI: 0735000201042620211208, 0735000201049520220312, 0735000201050120220422, 0735000201060020220620 and 0735000201057020221222. GTIN: 07350002010426, 07350002010495, 07350002010501, 07350002010600 and 07350002010570. Serial Numbers: 12.0.0.932, 12.1.0.1221 +7 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
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 for planning radiation therapy treatments for patients with cancer. Healthcare providers rely on accurate dose calculations for effective treatment.
Why This Is Dangerous
The software issue may prevent correct invalidation of radiation doses, especially for certain ROIs without contours. This can lead to serious treatment planning errors.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall necessitates immediate cessation of use to prevent potential harm to patients, affecting ongoing treatment plans and requiring urgent resolution.
Practical Guidance
How to identify if yours is affected
- Verify if your software version matches the recalled versions.
- Check if your model number is among those listed in the recall notice.
- Contact your healthcare provider for confirmation.
Where to find product info
Serial numbers and model numbers can typically be located in the software settings or installation documentation.
What timeline to expect
Expect a timeline of 4-8 weeks for refunds or replacements after contacting RaySearch Laboratories.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- Reach out to healthcare regulatory authorities for assistance.
- Consider consulting legal advice if necessary.
How to prevent similar issues
- Always check for software updates and recalls regularly.
- Verify that medical devices are certified by health authorities.
- Consult with healthcare professionals about device safety before use.
Documentation advice
Keep records of all communications regarding the recall, including emails and notes from phone calls.
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Product Details
Affected model numbers include 12.0.0, 12.1.0, 12.0.3, 12.0.4, and 12.3.0. The software versions include RayStation 11B, 11B SP1, 11B SP2, 11B SP3, and 11B SPT1.
Key Facts
- Recalled device: Radiation Therapy Treatment Planning System
- Software versions affected: RayStation 11B and updates
- Quantity recalled: 22 units
- Recall date: November 28, 2025
- Contact RaySearch Laboratories AB for instructions
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Safety Guide
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