# FDA recall Z-1078-2026

> **Elekta, Inc.** · Class II · device recall initiated 2025-12-10.

## Product

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

## Distribution

US Nationwide distribution in the state of TX.

## Key facts

- **Recall number:** Z-1078-2026
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-10
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1078-2026

## Citation

> AI Analytics. FDA recall Z-1078-2026. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/Z-1078-2026. Source: US FDA. Licensed CC0.

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