Z-0879-2026 Class II Ongoing

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

Recall Details

Product Type
Devices
Report Date
December 10, 2025
Initiation Date
October 24, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit (OUS only)

Product Description

MAMMOMAT Fusion;

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 Pattern

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

Code Information

Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 10559;