The Recall Desk
HighFDA (Devices)·Z-1982-2025·Announced 2025-06-25

UROSKOP Omnia Max Recalled for Fire Risk from Overheating Resistor

Siemens is recalling 25 UROSKOP Omnia Max imaging devices nationwide because a resistor in the frequency inverter may overheat, potentially igniting the plastic housing.

What this means for you

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 recall is classified as FDA Class II for a risk-of-harm product (fire/overheat) where no injuries or deaths have been reported. The potential fire hazard qualifies it as a high-severity risk despite the absence of reported incidents.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 25 units of the UROSKOP Omnia Max medical imaging device (Model Number 10762473).

A resistor in the frequency inverter may strongly overheat, potentially igniting the plastic housing of the frequency inverter. This creates a fire hazard.

The affected units were distributed nationwide.

The recalled product

Product
UROSKOP Omnia Max. Model Number: 10762473
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device
Hazard
  • electrical-overheat
  • fire

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.

Related recalls

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