Agency classClass IIOur severity:High FDA (Devices)·Z-1982-2025·Announced 2025-06-25

Siemens UROSKOP Omnia Max frequency inverter fire risk recalled

Siemens is recalling UROSKOP Omnia Max medical devices due to a resistor in the frequency inverter that may overheat and ignite the plastic housing. Twenty-five units distributed nationwide are affected.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a medical device with a significant risk of harm (fire hazard from component overheating). The source text does not report any illnesses, injuries, or deaths, but the hazard (ignition of plastic housing) represents a credible risk of serious harm if the failure occurs.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the UROSKOP Omnia Max Model Number 10762473, a medical imaging device. The recall affects 25 units distributed nationwide.

A resistor in the frequency inverter may strongly overheat, potentially igniting the plastic housing of the frequency inverter on fire. This poses a fire hazard to users and facilities where the device is operated.

Affected customers who own or operate UROSKOP Omnia Max Model Number 10762473 should contact Siemens Medical Solutions USA, Inc. for guidance on the device and the recall. Specific UDI numbers and serial numbers for the affected units have been identified by the FDA.

The recalled product

Product: UROSKOP Omnia Max. Model Number: 10762473
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: fire
overheat
Affected units: 25

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 (20)

Model Number: 10762473. UDI Numbers: (01)04056869008981(21)4014
(01)04056869008981(21)4056
(01)04056869008981(21)4049
(01)04056869008981(21)4015
(01)04056869008981(21)4063
(01)04056869008981(21)4022
(01)04056869008981(21)4036
(01)04056869008981(21)4043
(01)04056869008981(21)4024
(01)04056869008981(21)4059
(01)04056869008981(21)4020
(01)04056869008981(21)4032
(01)04056869008981(21)4053
(01)04056869008981(21)4061
(01)04056869008981(21)4060
(01)04056869008981(21)4051
(01)04056869008981(21)4025
(01)04056869008981(21)4037
(01)04056869008981(21)4054
(01)04056869008981(21)4042

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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