FDA-Device2019-03-13Class II

Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

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
191
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0985-2019

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