Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ra…

Recall date
February 8, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0984-2019
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
US Nationwide Distribution

Why it was recalled

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

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 -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).

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