FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
- Recall number
- Z-1845-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
- Status
- Terminated
- Initiated
- 2013-08-28
- Posted
- 2014-06-21
- Terminated
- 2015-02-24
- 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.
- Root cause
- Software design
- Action
- Siemens sent a notification letter, dated August 28, 2013, to Affected customers. The letter identified the affected product, problem and actions to be taken. The letter provided work-around instructions and announced that a field modification was prepared to resolve the issue.
- 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.
- Lot, serial or model codes
- Model numbers 10094910, 10281013, and 10281163 with software version VB10G.
- 510(k) numbers
- K062623, K081722, K101491
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28