Recall Z-0877-2026 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Siemens Medical Solutions USA, Inc
MAMMOMAT Revelation;
| Date | Dec 3, 2025 (initiated Oct 24, 2025) |
| Status | Open, Classified |
| Reason | 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 | Component design/selection |
| Action | 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 t |
| Quantity | 7 units (3 US, 4 OUS) |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193166 | MAMMOMAT Revelation Siemens Medical Solutions USA, Inc., Jun 12, 2020 |