FDAFDA · Food and drugs·Recall number Z-0879-2026
MAMMOMAT Fusion;
Published December 10, 2025 · Recall initiated: October 24, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
- Lot
- Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 10559;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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