Recall Z-1387-2019— KaVo Dental Technologies LLC

Name: FDA recall Z-1387-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-29

Class II · Terminated

Class II FDA medical device recall by KaVo Dental Technologies LLC, initiated 2019-04-29, terminated 2020-11-25. It names one FDA 510(k) clearance: K172918. 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.. Reason: The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality..

Recalling firm: KaVo Dental Technologies LLC
Classification: Class II
Status: Terminated
Initiated: 2019-04-29
Terminated: 2020-11-25
Firm location: Charlotte, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K172918 — DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)Kavo Dental Technologies, LLC·cleared 2017-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.