Recall Z-1845-2014 ยท KPR System, X-Ray, Stationary
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
| Date | Jun 21, 2014 (initiated Aug 28, 2013) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |