Recalls / —
—#122034
Product
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
- FDA product code
- KPR — System, X-Ray, Stationary
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K062623, K081722, K101491
- Affected lot / code info
- Model numbers 10094910, 10281013, and 10281163 with software version VB10G.
Why it was 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.
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355
Distribution
- 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.
Timeline
- Recall initiated
- 2013-08-28
- Posted by FDA
- 2014-06-21
- Terminated
- 2015-02-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #122034. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.