Siemens MAMMOMAT Fusion Operator Table Recalled for Bus-Installation Risk (2025)
One unit of the Siemens MAMMOMAT Fusion operator table is recalled after being sold with a bus-installation kit. The device is not intended for bus installations and is designed for stationary operation. Health care providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Quick Facts at a Glance
Recall Date
October 24, 2025
Hazard Level
HIGH
Brand
Siemens Medical Solutions USA
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions. Notification method: Letter
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About This Product
The MAMMOMAT Fusion is a stationary mammography imaging table used in clinical settings. This recall concerns the operator table being sold with a bus-installation kit, which is not intended or released for bus installations.
Why This Is Dangerous
Using a stationary table with a bus-installation kit creates a mismatch in installation and operation, potentially compromising device performance or patient safety.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to separate the operator table from bus installations, pause related imaging workflows, and coordinate with Siemens for proper remediation.
Practical Guidance
How to identify if yours is affected
Verify model number 10140000 on the device label.
Check UDI-DI 04056869009063 on packaging or device label.
Record system serial number 10559.
If matched, stop using immediately.
Where to find product info
Model number and UDI-DI are on the device label. System serial number is on the equipment card or label.
What timeline to expect
Remedies will be provided per recall instructions. Timeline depends on manufacturer process.
If the manufacturer is unresponsive
Escalate to hospital risk management and regulatory contacts.
File a consumer safety report with CPSC if applicable.
Seek guidance from your healthcare provider.
How to prevent similar issues
Do not couple stationary medical equipment with installation kits not intended for your setup.
Verify installation components before deployment.
Regularly review vendor recall notices for hospital equipment.
Documentation advice
Keep a copy of recall notices, take photos of device labels (model, UDI, serial number), document communications with the manufacturer and hospital risk management.
Product Details
Model Number: 10140000. UDI-DI: 04056869009063. System Serial Numbers: 10559. Sold Worldwide. US distribution in AR, CA, NY. Other countries: Australia, Canada, India.
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