CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report

Naeotom Alpha.Pro recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Naeotom Alpha.Pro, distributed nationwide in the US. The recall was initiated on 19 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaterial Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;

Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1242-2026
FDA event ID: 98206
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 19 Dec 2025
FDA classified: 3 Feb 2026
Reported: 11 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

19 Dec 2025	Recall initiated by company
3 Feb 2026	Classified by FDA	+46 days
11 Feb 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 98206

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026	CLASS II	Somatom X.ceed recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
11 Feb 2026	CLASS II	Naeotom Alpha recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
11 Feb 2026	CLASS II	Naeotom Alpha.Prime recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
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8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

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