FDA-Device2013-12-04Class II
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
Siemens Medical Solutions USA, Inc
Hazard
A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.
Sold states
Worldwide Distribution - USA (nationwide) and internationally to Canada.
Affected count
357
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0374-2014Don't want to check this manually?
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