NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Class I - DangerousWhat Should You Do?
- Check if you have this product: Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc
- Reason for Recall:
- To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Product Codes/Lot Numbers:
Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1242-2026
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