Siemens Medical Solutions USA, Inc recalls Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anato…
- Recall date
- February 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0985-2019
- 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 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.
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