Z-1845-2014Class II

Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G

Name: Z-1845-2014 Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-08-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-08-28 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system on 2013-08-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1845-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-28
Posted: 2014-06-21
Terminated: 2015-02-24
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
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: Model numbers 10094910, 10281013, and 10281163 with software version VB10G.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1845-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1845-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-20

Product code KPR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)