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NAEOTOM Alpha.Pro recallZ-1242-2026 · Siemens Medical Solutions USA, Inc · initiated Dec 19, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

On December 19, 2025, CUSTOMER ADVISORY NOTICE letters were sent to customers. Actions to be taken: 1. Stop all use of the Applications in patient care setting. 2. Please notify and instruct all staff at your organization who need to be aware of this matter. 3. Please ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein. 4. Please ensure that this advisory notice is retained in your product related records appropriately. Please keep this information until the corrective measures have been finalized. Actions by Siemens: Siemens Healthineers is expeditiously working to remove the Applications from your CT system(s) through a software update process. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436 if you have any questions.

Recall details

Recall number
Z-1242-2026
Status
Open, Classified
Initiated by the company
Dec 19, 2025
Posted by the FDA
Feb 3, 2026
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
2 units
Product code
JAK
FDA submissions
K251061
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.

Product description

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

Code information (models, lots, serial numbers)

Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K251061 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98206).

Sources and updates

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