# FDA recall Z-2406-2021

> **Elekta Inc** · Class II · device recall initiated 2021-07-26.

## Product

Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

## Reason for recall

If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

## Distribution

Distribution in US - IA, NJ, NY, TN, PA, TX, and WI  OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom

## Key facts

- **Recall number:** Z-2406-2021
- **Recalling firm:** Elekta Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-26
- **Report date:** 2021-09-08

- **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-2406-2021

## Citation

> AI Analytics. FDA recall Z-2406-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2406-2021. Source: US FDA. Licensed CC0.

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