Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0878-2026·Announced 2025-12-10

MAMMOMAT Inspiration systems recalled because operator tables shipped with bus-installation kits

Siemens Medical Solutions USA is recalling 6 MAMMOMAT Inspiration systems because operator tables were sold together with a bus-installation kit they are not released for.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites a component supplied outside its released installation type, with no stated consequence or reported harm.

Plain-English summary

The Siemens MAMMOMAT Inspiration is being recalled. The record lists model number 10140000, UDI-DI 04056869009063, and system serial numbers 6734, 6694, 10121, 10309, 10336 and 10342.

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.

The record lists 6 units, of which 3 are in the United States and 3 outside it. Distribution was worldwide, covering Arkansas, California and New York domestically and Australia, Canada and India internationally. The FDA has classified the action as Class II.

The record describes a component supplied for an installation type it was not released for, and states no injuries. Facilities should follow Siemens' instructions.

The recalled product

Product: MAMMOMAT Inspiration;
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Mammography system
Hazard: unreleased-configuration
installation
component-mismatch

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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