—#217161

Product

MAMMOMAT Fusion;

FDA product code: MUE — Full Field Digital, System, X-Ray, Mammographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K151645
Affected lot / code info: Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 10559;

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

On October 24, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: Please ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your personnel accordingly. Please ensure that this safety advisory is retained in your product related records appropriately. Please keep this information until the corrective measures have been finalized. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification. If this device/equipment is no longer in your possession, please forward this Customer Safety Advisory Notice to the new owner of this device. If applicable, please inform us about the new owner of the device.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.

Timeline

Recall initiated: 2025-10-24
Posted by FDA: 2025-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217161. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.