Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image
FDA device recall Z-1845-2014 · posted 2014-06-21 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 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.
- Date initiated
- 2013-08-28
- Date posted
- 2014-06-21
- Date terminated
- 2015-02-24
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UROSKOP OMNIA (K101491) | Siemens Medical Solutions USA, Inc. | 2010-06-30 |
| YSIO (K081722) | Siemens Medical Solutions USA, Inc. | 2008-08-22 |
| AXIOM LUMINOS DRF (K062623) | Siemens Medical Solutions USA, Inc. | 2007-08-22 |