FDAFDA · Food and drugs·Recall number Z-2072-2012
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Published October 10, 2012 · Recall initiated: June 19, 2012
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
It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Eos Imaging Inc
- Distributor
- Nationwide distribution
- Lot
- All associated Serial Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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