Siemens RAD Fluoro Uro System recall: Software Issue
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray…
Why was Siemens RAD Fluoro Uro System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model numbers 10094910, 10281013, and 10281163 with software version VB10G.
- Product
- Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 76
- Distribution
- 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.
- Recall date
- July 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)