SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Reported: February 11, 2026 Initiated: December 19, 2025 #Z-1239-2026
Product Description
SOMATOM X.ceed 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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 2 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 2 units.
Why was this product recalled? ▼
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1239-2026.
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