Recall Z-1078-2026 · IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
| Date | Jan 13, 2026 (initiated Dec 10, 2025) |
| Status | Open, Classified |
| Reason | 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 | Software change control |
| Action | 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://ww |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the state of TX. |
| FDA record | Open on fda.gov |