FDAFDA · Food and drugs·Recall number Z-0041-2014
Xoran MiniCAT CT Scanner ID ENT00001
Published November 6, 2013 · Recall initiated: December 14, 2009
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
Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Xoran Technologies, Inc.
- Distributor
- Worldwide Distribution - US nationwide
- Lot
- minicat
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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