MOSAIQ recallZ-1078-2026 · Elekta, Inc. · initiated Dec 10, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Software change control
What the company is doing
On 12/10/2025 correction notices were emailed to consignees who were asked to do the following: Radiation therapists must always check the meterset values displayed on the MOSAIQ console with the value displayed on the treatment unit console. If a mismatch occurs, follow Caution 9.6 in the MOSAIQ Instructions for Use. Complete and return the acknowledgement form. Firm is working on the correction and will release a Field Safety Modification with the details as soon as possible. Elekta Regional Contact Details: Region America: [email protected] Tel: +1 855 6935358 https://www.elekta.com Region Asia Pacific: [email protected] Tel: + 852 2891 2208 https://www.elekta.com Japan [email protected] Tel: + 81 3 6722 3800 Fax: +81 3 6436 4231 https://www.elekta.com Region China: [email protected] Tel : + 86 10 8012 5012 https://www.elekta.com Region Europe: [email protected] Tel : + 46 8 587 254 00 https://www.elekta.com Region Turkey, India & Middle East [email protected] Turkey Tel: +90 216 444 6374 India Tel: +1-800-103-7454 Middle East Tel: +00 800 4000 5000 https://www.elekta.com
Recall details
- Recall number
- Z-1078-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 10, 2025
- Posted by the FDA
- Jan 13, 2026
- Recalling firm
- Elekta, Inc.
- Quantity
- 1
- Product code
- IYE
- FDA submissions
- K203172, K223229
- Distribution
- US Nationwide distribution in the state of TX.
Product description
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Code information (models, lots, serial 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, 3.1.3.4, 3.2.0.0, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0, 3.2.3.1 UDI-DI: 07340201500026, 07340201500071
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- MOSAIQ 3.2Elekta Solutions AB · Accelerator, Linear, Medical4 recalls25 reports
- MOSAIQElekta Solutions AB · Accelerator, Linear, Medical3 recalls5 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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