DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium… — Class II medical device recall Z-1387-2019
Terminated recall by KaVo Dental Technologies LLC, reported 2019-05-29, distributed nationwide. The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in t
| Recall number | Z-1387-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KaVo Dental Technologies LLC, Charlotte, NC, United States |
| Recall initiated | 2019-04-29 |
| Classified | 2019-05-21 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2020-11-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 211 devices |
| Serial numbers | 13095594, 13095595, 13095599, 13095661, 13095665, 13095759, 13095762, 13095766, 13095769, 13095774, 13095780, 13095782, 13095783, 13095784, 13095786, 13095809, 13095810, 13095817, 13095823, 13095827, 13095839, 13095874, 13095876, 13095890, 13095897 and 186 more |
| Model numbers | CD63M115.CG, IOXS-1.012.6180 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1387-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.