[pending] MAMMOMAT Fusion;
Pending LLM rewrite. Source: FDA_DEVICE Z-0879-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- MAMMOMAT Fusion;
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: 10140000
- UDI-DI: 04056869009063
- System Serial Numbers: 10559
Distribution
Distributed nationwide across the United States.
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