KaVo Recalls DEXIS Titanium Intraoral Sensors Due to Calibration Error
KaVo Dental Technologies is recalling 211 DEXIS Titanium Intraoral Sensors because incorrectly programmed calibration files may reduce image quality.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a reduction in image quality rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity issue involving product performance.
Plain-English summary
KaVo Dental Technologies LLC is recalling 211 units of the DEXIS Titanium Intraoral Sensor. The recall was initiated because the sensor's look up calibration files were incorrectly programmed during manufacturing. This defect can result in a reduction of image quality for dental intraoral radiographic images.
The affected devices are identified by Model Number CD63M115.CG and Part Number IOXS-1.012.6180. The recall covers specific serial numbers listed in the official FDA notice. The devices were distributed nationwide in the United States to 33 states and internationally to Canada.
Healthcare professionals who use these sensors should stop using the affected units and contact KaVo Dental Technologies for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- 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…
- Manufacturer
- KaVo Dental Technologies LLC
- Category
- Medical Device — Dental Imaging
- Hazard
- Affected units
- 211
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number CD63M115.CG
- Part Number IOXS-1.012.6180
- Serial Numbers: 13095594
- 13095595
- 13095599
- 13095661
- 13095665
- 13095759
- 13095762
- 13095766
- 13095769
- 13095774
- 13095780
- 13095782
- 13095783
- 13095784
- 13095786
- 13095809
- 13095810
- 13095817
Distribution
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