# FDA recall Z-2091-2019

> **Elekta Inc** · Class II · device recall initiated 2019-07-03.

## Product

Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System

## Reason for recall

When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-2091-2019
- **Recalling firm:** Elekta Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-07-03
- **Report date:** 2019-08-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maryland Heights, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2091-2019

## Citation

> AI Analytics. FDA recall Z-2091-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2091-2019. Source: US FDA. Licensed CC0.

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