Device product
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
Z-1845-2014
Product summary
- Event
- Event 66315
- Status
- Terminated
- Classification
- Class II
- Quantity
- 76
- Official record key
device-enforcement:Z-1845-2014
Official wording
Reason: When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examination.
Code information: Model numbers 10094910, 10281013, and 10281163 with software version VB10G.
Distribution pattern: USA Nationwide Distribution in the states of OH, NJ, MA, CO, NY, CA, MD, OR, KY, PA, IL, VA, TX, MN, KS, GA, and WY.
Derived failure modes
-
Device software or design
software versions VD10A/G during a RAD examination, a malfunction