Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0877-2026·Announced 2025-12-10

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

Siemens Medical Solutions USA is recalling 7 MAMMOMAT Revelation 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 Revelation is being recalled. The record lists model number 11343300, UDI-DI 04056869124575, and system serial numbers 1296, 10550, 10572, 10606, 10608, 11511 and 20140.

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 7 units, of which 3 are in the United States and 4 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 Revelation;
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 (9)

Model Number: 11343300
UDI-DI: 04056869124575
System Serial Numbers: 1296
10550
10572
10606
10608
11511
20140

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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