CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report

Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia recalled

Siemens Medical Solutions USA is recalling Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia, distributed nationwide in the US. The recall was initiated on 3 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel numbers 10094910 and 10094200 with software version VD10A/G.

Quantity recalled59

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0140-2014
FDA event ID: 66314
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 3 Sep 2013
FDA classified: 27 Nov 2013
Reported: 4 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

3 Sep 2013	Recall initiated by company
27 Nov 2013	Classified by FDA	+85 days
4 Dec 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to Canada.

Nationwide

Questions about this recall

Is Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia recalled?

Yes. Siemens Medical Solutions USA recalled Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia on 3 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0140-2014.

Why was it recalled?

Which lots are affected?

Model numbers 10094910 and 10094200 with software version VD10A/G.

Where was it sold?

Worldwide Distribution - USA (nationwide) and Internationally to Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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