Siemens Medical Solutions USA, Inc recalls MAMMOMAT Fusion

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.

MAMMOMAT Fusion;

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.

• FDA enforcement recordOfficial FDA database entry for Z-0879-2026
• FDA 510(k) clearance · K151645The device's official FDA premarket clearance record
• FDA device classification · MUEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1715The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Siemens Medical Solutions USA, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.