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Recall Observatory FDA recall evidence

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

August 28, 2013

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
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

    reason.device_software_design · v1.0.0

    software versions VD10A/G during a RAD examination, a malfunction