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Siemens Medical Solutions USA, Inc recalls Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluorosc
Recalled December 4, 2013 · FDA recall Z-0140-2014 · Siemens Medical Solutions USA
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. · FDA Class II
Units
59
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Description
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.
Product
Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →