FDAFDA · Food and drugs·Recall number Z-0140-2014
Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system
Published December 4, 2013 · Recall initiated: September 3, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Canada.
- Lot
- Model numbers 10094910 and 10094200 with software version VD10A/G.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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