Z-2292-2014Class II

Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a...

Name: Z-2292-2014 Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-07-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-07-07 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and... on 2014-07-07. FDA classified it as Class II and gives the reason as "It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2292-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-07
Posted: 2014-09-10
Terminated: 2015-02-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. Thi
Root cause tag: design
FDA root cause: Device Design
Action: Siemens had informed all affected customers about this issue via Customer Safety Advisory Notice XP023/13/S (dated June 3, 2013) reported under C&R # 2240869-05/16/13-0013-C. A corresponding software update to fix the issue was originally planned to be rolled out by May 2014. The originally scheduled roll out date could not be met and to ensure that this new software version works accurately Siemens incorporated a comprehensive monitoring phase. Siemens has now scheduled the roll out for the software version VB10J to be completed by end of October 2014. A letter, dated July 7, 2014, with important safety information was sent to end users to notify them that the new software version VB10J will be introduced to solve the potential malfunction of the generator.
Quantity in commerce: 192
Distribution: Nationwide Distribution.
Product codes and lots: model numbers 10094200, 10281163, 10281013, 10094910 with multiple serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2292-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2292-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-10

Product code JAA

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)