MAMMOMAT Revelation;
FDA Recall Z-0877-2026 · Posted 2025-12-03
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeMUE
Date Initiated2025-10-24
Product Quantity7 units (3 US, 4 OUS)
Reason for Recall
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.
Firm 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 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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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