Quick Facts at a Glance
- Recall Date
- December 10, 2025
- Hazard Level
- HIGH
- Brand
- Elekta
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- 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
- Elekta
- Product type
- Oncology Information System
- Model numbers
- MOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base. Software Versions: 3.10.200, 3.1.1.0, 3.1.2.0, 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3 +12 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 10, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Elekta, Inc. or your healthcare provider for instructions
About This Product
The MOSAIQ Oncology Information System is designed to manage workflow in oncology treatment settings. Healthcare providers use it to ensure accurate administration of cancer therapies, including particle therapy.
Why This Is Dangerous
The system's software may incorrectly handle treatment plans, leading to potential overtreatment if proper checks are not conducted. This flaw can result in patients receiving more treatment than necessary, posing serious health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers' ability to deliver safe treatments, potentially delaying patient care and requiring adjustments to workflows.
Practical Guidance
How to identify if yours is affected
- Check if your oncology information system is the MOSAIQ model mentioned in the recall.
- Verify the software version against the affected versions listed in the recall.
- Contact Elekta directly with your product details for confirmation.
Where to find product info
Serial numbers and software versions can typically be found in the system settings or on the device's identification label.
What timeline to expect
Expect a response from Elekta regarding the recall instructions within a few days of reporting.
If the manufacturer is unresponsive
- Document all communication attempts with Elekta.
- Consider reaching out to the FDA or relevant regulatory body if you do not receive a response.
How to prevent similar issues
- Look for updated software versions in future purchases.
- Ensure that any medical device has passed FDA safety certifications before use.
- Consult peer reviews and safety records of similar products before adoption.
Documentation advice
Keep records of all communications regarding the recall, including emails, phone calls, and any correspondence received from Elekta.
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Product Details
The recall affects the MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO). The software versions involved include MOSAIQ v 3.10.200 and earlier versions up to v 3.2.3.1 with Particle Base. Distribution occurred nationwide in the United States, particularly Texas.
Key Facts
- Recall date: December 10, 2025
- Class II recall
- Potential for overtreatment
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