# FDA recall Z-2447-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-08-16.

## Product

MR MAGNETOM Systems with  RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT     Material Numbers: 11060815

## Reason for recall

Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2447-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-16
- **Report date:** 2021-09-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2447-2021

## Citation

> AI Analytics. FDA recall Z-2447-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2447-2021. Source: US FDA. Licensed CC0.

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