Quick Facts at a Glance
- Recall Date
- October 24, 2025
- Hazard Level
- HIGH
- Brand
- Siemens Medical Solutions USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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 for mammography system
- Model numbers
- 10140000, UDI-DI 04056869009063, System Serial Numbers: 6734,6694,10121,10309,10336,10342
- Sold at
- Multiple Retailers
- 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 Inspiration is a mammography imaging system. The operator table is part of the installation setup and is typically used in stationary configurations inside clinics or hospitals.
Why This Is Dangerous
The table was sold with a bus-installation kit and is not intended or released for bus installations. The design is for stationary operation only, creating installation-related risks when used in bus configurations.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Healthcare facilities may need to discontinue use of the affected table and coordinate with Siemens for proper remediation. No patient injuries have been reported in connection with this issue.
Practical Guidance
How to identify if yours is affected
- Verify model number 10140000 on the unit label
- Compare system serial numbers against 6734, 6694, 10121, 10309, 10336, 10342
- Confirm presence of a bus-installation kit with the operator table
- Review purchase records to determine if the unit is among the recalled six
Where to find product info
Model number and serial numbers are located on the unit label; UDI-DI appears on packaging and documentation
What timeline to expect
Refunds or replacements typically take several weeks; Siemens will provide specific instructions
If the manufacturer is unresponsive
- Document all correspondence with Siemens
- Escalate to hospital risk management or CPSC if needed
- Consider filing a formal complaint with the recall authority if there is no response
How to prevent similar issues
- For future purchases, ensure any installation kits are approved for the intended installation
- Review product installation documentation before deployment
- Maintain a centralized record of all installed medical imaging equipment and installation configurations
- Ask manufacturers for written confirmation of installation compatibility before purchase
Documentation advice
Keep copies of all recall notices, purchase records, packaging, and correspondence with Siemens for your records
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Product Details
Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 6734, 6694, 10121, 10309, 10336, 10342; Sold worldwide; US distribution in AR, CA, NY; Manufacturer: Siemens Medical Solutions USA; Recall Date: 2025-10-24; Report Date: 2025-12-10; Status: ACTIVE; Hazard: Bus-installation kit used with operator table not intended for bus installations; Category: Medical Devices; Brand: Siemens; Product: MAMMOMAT Inspiration operator table; Quantity: 6 units (3 US, 3 OUS)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 6 total units recalled (3 US, 3 OUS)
- Model 10140000 and UDI 04056869009063
- Bus-installation kit paired with operator table
- Hazard is lack of approval for bus installations
- Active recall as of 2025-12-10
- Worldwide distribution; US states AR, CA, NY affected
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Safety Guide
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