Siemens Medical Solutions USA, Inc: MAMMOMAT Fusion;
Read the official notice at FDA (device) →
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Siemens Medical Solutions USA, Inc
- Product
- MAMMOMAT Fusion;
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
- Recall initiated
- 2025-10-24
- Code info
- Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 10559;
- Product quantity
- 1 unit (OUS only)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Malvern
- State
- PA
- Country
- United States
- Event id
- 97920
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