FDA DevicesClass II
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 4...
Published: January 21, 2026Recall ID: Z-1078-2026Category: devicesCountry: US
Reason for Recall / Hazard
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
Product Description & Identification
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Affected Products
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Additional Source Details
| Field | Value |
|---|---|
| City | Atlanta |
| State | GA |
| Event id | 98116 |
| Address 1 | 400 Perimeter Center Ter NE Ste 50 |
| 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 |
| Postal code | 30346-1227 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 1 |
| Reason for recall | 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251210 |
| Center classification date | 20260113 |
Overview
- Recalling FirmElekta, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of TX.