FDAHealthOctober 24, 2025
Siemens Medical Solutions USA, Inc — MAMMOMAT Fusion;
⚠️ 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 Fusion;
- Lot code
- Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 10559;
Additional details
Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 10559;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 unit (OUS only).
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