FDA-Device2013-11-13Class II
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
Siemens Medical Solutions USA, Inc
Hazard
Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho
Sold states
Nationwide Distribution
Affected count
23
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0016-2014Don't want to check this manually?
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