FDAFDA · Food and drugs·Recall number Z-0192-2015
OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
Published November 19, 2014 · Recall initiated: October 3, 2014
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
GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE OEC Medical Systems, Inc
- Distributor
- Worldwide Distribution.
- Lot
- Serial No: P4-0490-R and P6-0705-L
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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