The Recall Desk
ModerateFDA (Devices)·Z-0879-2026·Announced 2025-12-10

MAMMOMAT Fusion system recalled because an operator table shipped with a bus-installation kit

Siemens Medical Solutions USA is recalling one MAMMOMAT Fusion system because an operator table was sold together with a bus-installation kit it is not released for.

What this means for you

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 Fusion is being recalled. The record lists model number 10140000, UDI-DI 04056869009063, and system serial number 10559.

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 1 unit, outside the United States only. 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 Fusion;
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Mammography system
Hazard
Affected units
1

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 (3)

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

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 →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc

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Same hazard · unreleased configuration

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