FDAFDA · Food and drugs·Recall number Z-0374-2014
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 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
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.
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: 10094200, 10094910, 10281013, 10281163, 10502200
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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