FDAFDA · Food and drugs·Recall number Z-0129-2016
Owandy Radiology I -MAX Touch 3D X-ray
Published November 18, 2015 · Recall initiated: August 5, 2015
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 has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Villa Radiology Systems LLC
- Distributor
- US Distribution
- Lot
- p/n 9306251191 and 9306651191
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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