FDAFDA · Food and drugs·Recall number Z-0580-2014
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
Published January 1, 2014 · Recall initiated: November 29, 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
Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- EOS Imaging
- Distributor
- USA Nationwide Distribution
- Lot
- Software versions: 1.3, 1.4 and 1.5
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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