FDAFDA · Food and drugs·Recall number Z-0193-2015
OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
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: 86-0039,86-0135,86-0191,86-0318,86-0334,86-0587,86-0611,86-0619,86-0758,86-0782,86-0931,86-0935-RC,86-1129,86-1220,86-1241,86-1376,86-1432,86-1503,86-1551,86-1614,86-1678,86-1702,86-1736,86-1959,86-2092,86-2119
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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