# FDA recall Z-1825-2020

> **Elekta Inc** · Class II · device recall initiated 2020-04-16.

## Product

Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The

## Reason for recall

The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.

## Distribution

Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom.

## Key facts

- **Recall number:** Z-1825-2020
- **Recalling firm:** Elekta Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-04-16
- **Report date:** 2020-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Charles, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1825-2020

## Citation

> AI Analytics. FDA recall Z-1825-2020. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-1825-2020. Source: US FDA. Licensed CC0.

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