Class II

Medical Device Recall: MAMMOMAT Revelation;

Siemens Medical Solutions USA, Inc · October 24, 2025

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.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

7 units (3 US, 4 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0877-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.