# FDA recall Z-2563-2021

> **Elekta Inc** · Class II · device recall initiated 2021-09-14.

## Product

Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.

## Reason for recall

Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of PA, MI, WI, NY, TN, NJ, IA, TX and the countries of United Kingdom, Turkey, Switzerland, Sweden, Spain, Netherlands, Korea, Thailand, Japan, Italy, Hong Kong, Germany, France, Denmark, China, Canada, Belgium, Bahrain, Australia.

## Key facts

- **Recall number:** Z-2563-2021
- **Recalling firm:** Elekta Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-14
- **Report date:** 2021-10-06

- **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-2563-2021

## Citation

> AI Analytics. FDA recall Z-2563-2021. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-2563-2021. Source: US FDA. Licensed CC0.

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