See Supplemental Directions on ģ.) For any affected devices that are unopened or uninstalled, return them to KaVo Dental Technologies, LLC.
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 Ģ.) For any affected devices that are installed, stop usage and contact Customer Care at 1-88 (Option 1) to start the correction via remote connection. KaVo Dental Technologies, LLC notified customers on about, via "URGENT: MEDICAL DEVICE RECALL - CORRECTION" letter. The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality. 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. 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 Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images.
System, x-ray, extraoral source, digital - Product Code MUH Class 2 Device Recall DEXIS Titanium Intraoral Sensor