Z-0374-2014Class II

(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software...

Name: Z-0374-2014 (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software...
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-09-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-09-03 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray... on 2013-09-03. FDA classified it as Class II and gives the reason as "A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required...". 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-0374-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-03
Posted: 2013-11-26
Terminated: 2015-02-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
Product code: KPR System, X-Ray, Stationary
Reason for recall: A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.
Root cause tag: software
FDA root cause: Software design
Action: Siemens Healthcare sent a Field Safety Notice dated September 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Field Safety Notice to any new users and provide the new owner information to Siemens Healthcare. Customers were asked to send back the attached form confirming receipt of the Field Safety Notice. Customers with questions should call 610-850-4634. For questions regarding this recall call 610-219-6300.
Quantity in commerce: 357
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Canada.
Product codes and lots: Model numbers: 10094200, 10094910, 10281013, 10281163, 10502200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0374-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0374-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

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)