Recall Z-1845-2014— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-08-28, terminated 2015-02-24. It names 3 FDA 510(k) clearances: K101491, K081722, K062623. Product: Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system. 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-28
- Terminated
- 2015-02-24
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
3 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.