# FDA recall Z-0942-2022

> **Varian Medical Systems Imaging Laboratory GmbH** · Class II · device recall initiated 2022-03-21.

## Product

ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

## Reason for recall

Software issue for treatment plan and image management application may result in mismatch values which could result in  treatment in the wrong location

## Distribution

Worldwide distribution - US Nationwide distribution in the states of MI, KS, OH, VA, DC, FL, PA, OK, MN, AZ and the countries of South Korea, Netherlands, Poland, China.

## Key facts

- **Recall number:** Z-0942-2022
- **Recalling firm:** Varian Medical Systems Imaging Laboratory GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-03-21
- **Report date:** 2022-04-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baden, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0942-2022

## Citation

> AI Analytics. FDA recall Z-0942-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0942-2022. Source: US FDA. Licensed CC0.

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