Charlotte, NC, United States
KaVo Dental Technologies LLC recalls
2 recalls recorded since 2018, most recently on 29 April 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 29 April 2019
- Terminated
- 25 November 2020
- Reason
- The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
- Distribution
- Worldwide Distribution - US Nationwide to AL, AR, AZ, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, OH, OK, PA, TN, TX, VA, WA, WI, WV and internationally to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1387-2019
- DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated b
Ongoing Class II Medical devices
- Recall started
- 31 December 2018
- Reason
- ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
- Distribution
- US distribution in NC
- Initiated
- FDA Mandated
- Recall number
- Z-1101-2019
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.