FDA-Device2019-03-13Class II

Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).

Siemens Medical Solutions USA, Inc
Hazard

The swivel arm holding the monitors may become dislodged from the carrying arm.

Sold states
US Nationwide Distribution
Affected count
6
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0984-2019

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