FDAFDA · Food and drugs·Recall number Z-1101-2019
cone-beam CT system
Published May 1, 2019 · Recall initiated: December 31, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- KaVo Dental Technologies LLC
- Distributor
- US distribution in NC
- Lot
- versions 2.1.0 and 2.1.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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