# FDA recall Z-1387-2019

> **KaVo Dental Technologies LLC** · Class II · device recall initiated 2019-04-29.

## 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 for recall

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

## 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.

## Key facts

- **Recall number:** Z-1387-2019
- **Recalling firm:** KaVo Dental Technologies LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-29
- **Report date:** 2019-05-29
- **Termination date:** 2020-11-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Charlotte, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1387-2019

## Citation

> AI Analytics. FDA recall Z-1387-2019. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1387-2019. Source: US FDA. Licensed CC0.

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