FDA-Device2013-12-04Class II
Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system
Siemens Medical Solutions USA, Inc
Hazard
When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Affected count
59
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0140-2014Don't want to check this manually?
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