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Z-0878-2026Class II

Siemens Medical Solutions USA, Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Siemens Medical Solutions USA, Inc
Product type
Device
Status
Ongoing
Report date
2025-12-10
Distribution
Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
Firm state
PA
Product quantity
6 units (3 US, 3 OUS)
Initiated by
Voluntary: Firm initiated
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.

Product description

MAMMOMAT Inspiration;

Code / lot info

Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 6734, 6694, 10121, 10309, 10336, 10342;

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →