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: 0735000201047120220131 GTIN: 07350002010471 Serial Numbers: 10.1.1.54 Software Revision: RayStation 10B SP1 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
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
The RayStation/RayPlan system is a radiation therapy planning tool used by healthcare providers to calculate radiation doses for cancer treatment. It is utilized in clinical settings for its precision in treatment planning.
Why This Is Dangerous
The hazard arises when certain Regions of Interest lack contours or have material overrides, leading to incorrect dose calculations. This can result in inadequate or excessive radiation exposure to patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this system may face delays in treatment or potential health risks due to improper dosing, thus emphasizing the urgency of addressing the recall.
Practical Guidance
How to identify if yours is affected
- Verify the model number as 10.1.1 and software version as RayStation 10B SP1.
- Check for any communications from RaySearch Laboratories AB regarding the recall.
- Consult your healthcare provider to determine if your system is affected.
Where to find product info
Look for the model number and software version in the system settings or documentation provided with the device.
What timeline to expect
Expect a processing timeline of approximately 4-6 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer or healthcare provider.
- Contact the relevant health authority if there is no response.
How to prevent similar issues
- Always verify the latest software updates before use.
- Ensure that the device is regularly checked for recalls and safety alerts.
Documentation advice
Keep records of your communication with the manufacturer and any relevant documents regarding the device.
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Product Details
The recall involves the RayStation/RayPlan system, model number 10.1.1, software version RayStation 10B SP1. The product is used for radiation therapy treatment planning. Specific lot code for reference: UDI: 0735000201047120220131.
Key Facts
- Device: RayStation/RayPlan
- Software Version: RayStation 10B SP1
- Recall Date: November 28, 2025
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Safety Guide
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