# FDA recall Z-2297-2020

> **Elekta Limited** · Class II · device recall initiated 2020-05-21.

## Product

Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571

## Reason for recall

In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.

## Distribution

US distribution to IA, NY, PA, TX, WI.      International distribution to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Turkey, United Kingdom.

## Key facts

- **Recall number:** Z-2297-2020
- **Recalling firm:** Elekta Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-21
- **Report date:** 2020-06-17
- **Termination date:** 2024-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crawley, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2297-2020

## Citation

> AI Analytics. FDA recall Z-2297-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2297-2020. Source: US FDA. Licensed CC0.

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