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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Siemens Medical Solutions USA
- Product type
- Operator Table
- Model numbers
- 10140000
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 24, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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.
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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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution with US AR, CA, NY
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Safety Guide
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