Medical device recalls Moderate risk

UROSKOP Omnia recalled over fire hazard

Recall date
June 4, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Siemens Medical Solutions USA, Inc recalls UROSKOP Omnia. Model Number: 10094910
Recall number
Z-1981-2025
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

UROSKOP Omnia. Model Number: 10094910

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