NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPE
Summary
The FDA issued a Class II for NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo by Siemens Medical Solutions USA, Inc. Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance..
Details
Source
Device Recall
External ID
Z-1242-2026
Action Date
2026-02-11
Status
Ongoing
Category
device
Product Description
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Lot/Code Info: Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;
Quantity Affected: 2 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-19
Company
Malvern, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 207 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc have FDA actions?
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1242-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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