CLASS II ONGOING Device recall · Reported 10 Dec 2025 · FDA Enforcement Report

Mammomat Revelation recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Mammomat Revelation, distributed nationwide in the US. The recall was initiated on 24 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 11343300; UDI-DI: 04056869124575; System Serial Numbers: 1296, 10550, 10572, 10606, 10608, 11511, 20140;

Quantity recalled7 units (3 US, 4 OUS)

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-0877-2026
FDA event ID: 97920
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Oct 2025
FDA classified: 3 Dec 2025
Reported: 10 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Oct 2025	Recall initiated by company
3 Dec 2025	Classified by FDA	+40 days
10 Dec 2025	Published in enforcement report	+7 days

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

Reason for recall

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Product as listed by the FDA

MAMMOMAT Revelation;

Where it was distributed

Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.

Nationwide Arkansas California New York

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Number: 11343300; UDI-DI: 04056869124575; System Serial Numbers: 1296, 10550, 10572, 10606, 10608, 11511, 20140;

Where was it sold?

Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.

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

2 other products · FDA event 97920

This product is part of a recall event; the main page for the event is Mammomat Inspiration recalled by Siemens Medical Solutions USA.

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025	CLASS II	Mammomat Inspiration recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Dec 2025	CLASS II	Mammomat Fusion recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	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
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
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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