NAEOTOM Alpha.Pro Software applications: syngo.CT Brain recall: Software Issue
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Why was NAEOTOM Alpha.Pro Software applications: syngo.CT Brain recalled?
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;
- Product
- NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 2 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
- Recall date
- February 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)