Recall – Intraoral sensor software error causes reduction in image quality

Company: KaVo Dental Technologies LLC
Date of Enforcement Report: 5/29/2019
Class II

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.

Recall Number: Z-1387-2019

REASON

The sensor’s look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.

RECALLING FIRM/MANUFACTURER

KaVo Dental Technologies LLC on 4/29/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
211 devices

DISTRIBUTION

US Nationwide and International

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.