The Recall Desk
HighFDA (Devices)·Z-1981-2025·Announced 2025-06-25

[pending] UROSKOP Omnia. Model Number: 10094910

Pending LLM rewrite. Source: FDA_DEVICE Z-1981-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

The recalled product

Product
UROSKOP Omnia. Model Number: 10094910
Manufacturer
Siemens Medical Solutions USA, Inc

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: 10094910. No UDI. Serial Numbers: 3054
  • 3029
  • 3062
  • 3169
  • 3402
  • 3103
  • 3053
  • 3055
  • 3072
  • 3019
  • 3048
  • 3403
  • 3058
  • 1045
  • 2014
  • 3091
  • 3013
  • 3023
  • 3115
  • 3051

Distribution

Distributed nationwide across the United States.