cone-beam CT system
Class I - DangerousWhat Should You Do?
- Check if you have this product: versions 2.1.0 and 2.1.1
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- KaVo Dental Technologies LLC
- Reason for Recall:
- ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
cone-beam CT system
Product Codes/Lot Numbers:
versions 2.1.0 and 2.1.1
Distribution:
Distributed in: US, NC
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1101-2019
Related Recalls
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.