Elekta, Inc. 2026-01-21 Health serious FDA
Health · FDA · Recall #FDA-Z-1078-2026
MOSAIQ Oncology Information System with Particle Therapy License (License Kit… Recall
Issued January 21, 2026 · Elekta, Inc.
In January 2026, Elekta, Inc. recalled the MOSAIQ Oncology Information System with Particle Therapy License (License Kit…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
- 1 Stop using MOSAIQ Oncology Information System with Particle Therapy License (License Kit… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Elekta, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Elekta, Inc.
- Category
- Health
- Recall date
- January 21, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the state of TX.
- Recall number
- FDA-Z-1078-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Elekta, Inc. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.