Recall Z-1387-2019 ยท MUH System, X-Ray, Extraoral Source, Digital
KaVo Dental Technologies LLC
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
| Date | Apr 29, 2019 |
| Status | Terminated |
| Reason | The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality. |
| Root cause | Device Design |
| Action | KaVo Dental Technologies, LLC notified customers on about 04/29/2019, via "URGENT: MEDICAL DEVICE RECALL - CORRECTION" letter. Customers were instructed to: 1.) Review the serial number information included with this letter and identify where the affected devices are located in your facility; 2.) For any affected devices that are installed, stop usage and contact Customer Care at 1-888-883-3947 (Option 1) to start the correction via remote connection. See Supplemental Directions on Page 2; 3.) For any affected devices that are unopened or uninstalled, return them to KaVo Dental Technologi |
| Quantity | 211 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) Kavo Dental Technologies, LLC, Dec 18, 2017 |