FDA recall, , Moderate risk
Elekta MOSAIQ Oncology Information System with Particle Therapy License
The Mosaiq Oncology Information System with Particle Therapy License may deliver partial treatment twice, causing overtreatment.
Summary by Recall Canary from the FDA notice
What happened
Elekta, Inc., of Atlanta, Georgia, began a recall of the MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) on December 10, 2025, and the FDA added it to its Enforcement Report on January 13, 2026.
The system, which manages workflow, may deliver partial treatment twice, resulting in overtreatment, when used with the Particle Therapy IHE-RO TDW-II interface, with one field per fraction or last field partial treatment, and when partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment, and the treatment unit does not check the meterset value.
The recall was classified by the FDA on January 13, 2026, and the product was distributed in the state of Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
- UDI-DI
- 07340201500026
- 07340201500071
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Texas.
- Company
- Elekta, Inc.Atlanta, Georgia
- Hazard
- Foreign object
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98116
- Recall number
- Z-1078-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
