Class IIReported 2025-12-10

MAMMOMAT Fusion;

Recalled by Siemens Medical Solutions USA, Inc

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.

Recall Number

Z-0879-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-10-24

Reported

2025-12-10

Distribution

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

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.