FDAFDA · Food and drugs·Recall number Z-0194-2015
FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System 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: 3120PU3, 4851PU2, 5640PU8, 6052PU5, FIB0064
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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