# FDA recall Z-1241-2026

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2025-12-19.

## Product

NAEOTOM Alpha.Prime  Software applications:   syngo.CT Brain Quantification  syngo.CT Vessel Hyperdensities  syngo.CT ASPECTS

## Reason for recall

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.

## Key facts

- **Recall number:** Z-1241-2026
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-19
- **Report date:** 2026-02-11

- **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-1241-2026

## Citation

> AI Analytics. FDA recall Z-1241-2026. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1241-2026. Source: US FDA. Licensed CC0.

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