—#217642

Product

MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K203172, K223229
Affected lot / code info: 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

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

Root cause (FDA determination)

Software change control

Action the firm took

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: Application.Support.NA@elekta.com Tel: +1 855 6935358 https://www.elekta.com Region Asia Pacific: HK.TW.Support@elekta.com Tel: + 852 2891 2208 https://www.elekta.com Japan Japan-fco@elekta.com Tel: + 81 3 6722 3800 Fax: +81 3 6436 4231 https://www.elekta.com Region China: FCO.CN@elekta.com Tel : + 86 10 8012 5012 https://www.elekta.com Region Europe: Support.europe@elekta.com Tel : + 46 8 587 254 00 https://www.elekta.com Region Turkey, India & Middle East support.rma@elekta.com Turkey Tel: +90 216 444 6374 India Tel: +1-800-103-7454 Middle East Tel: +00 800 4000 5000 https://www.elekta.com

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: US Nationwide distribution in the state of TX.

Timeline

Recall initiated: 2025-12-10
Posted by FDA: 2026-01-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217642. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.