FDAFDA · Food and drugs·Recall number Z-0529-2014
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Published January 15, 2014 · Recall initiated: November 7, 2013
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
EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- EOS Imaging
- Distributor
- Nationwide Distribution
- Lot
- EOS System
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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