Home / Recalls / Medical Devices
KaVo Dental Technologies LLC recalls DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is i
Recalled May 29, 2019 · FDA recall Z-1387-2019 · KaVo Dental Technologies
Hazard
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality. · FDA Class II
Units
211 devices
Sold at
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.
Description
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
Product
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 by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
Manufacturer(s)
KaVo Dental Technologies LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →