# FDA recall Z-0965-2019

> **Elekta, Inc.** · Class II · device recall initiated 2019-02-08.

## Product

Monaco Radiation Treatment Planning (RTP) System

## Reason for recall

If  Improve Target Dose  was chosen as an optimization model in a previous treatment session, Monaco¿ will  automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

## Distribution

Domestic distribution to Wisconsin, Texas.      International distribution to Denmark, England, Germany, Netherlands, Sweden.

## Key facts

- **Recall number:** Z-0965-2019
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-08
- **Report date:** 2019-03-06
- **Termination date:** 2024-08-19

- **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-0965-2019

## Citation

> AI Analytics. FDA recall Z-0965-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0965-2019. Source: US FDA. Licensed CC0.

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