29

May

2019

Recall – Intraoral sensor software error causes reduction in image quality

recall, softwareerror

0

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

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