FDAHealthOctober 24, 2025

Siemens Medical Solutions USA, Inc — MAMMOMAT Revelation;

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: October 24, 2025

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

What's affected?

Product: MAMMOMAT Revelation;
Brand: Siemens Medical Solutions USA, Inc
Lot code: Model Number: 11343300; UDI-DI: 04056869124575; System Serial Numbers: 1296, 10550, 10572, 10606, 10608, 11511, 20140;

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 7 units (3 US, 4 OUS).

View original FDA notice →

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