Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1387-2019 — 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 acquis

U.S. FDA — Device Enforcement · United States · 2019-04-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1387-2019
Date of alert
2019-04-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
KaVo Dental Technologies LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
13095594
Reported risk: The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.