MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Reported: January 21, 2026 Initiated: December 10, 2025 #Z-1078-2026
Product Description
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
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
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 1
- Distribution
- US Nationwide distribution in the state of TX.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO). Recalled by Elekta, Inc.. Units affected: 1.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2026. Severity: Moderate. Recall number: Z-1078-2026.
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