Reported May 29, 2019 · Terminated
DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is…
KaVo Dental Technologies LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: KaVo Dental Technologies LLC · 11727 Fruehauf Dr · Charlotte, NC · 28273-6507
Is this the product you have?
- DEXIS
- Titanium Intraoral Sensor Product UsageThe 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
- Lot codes and dates
Model Number CD63M115.CGPart Number IOXS-1.012.6180
- Serial Numbers
211 of 211 codes
130955941309559513095599130956611309566513095759130957621309576613095769130957741309578013095782130957831309578413095786130958091309581013095817130958231309582713095839130958761309589013095897130958991309590013095921130959271309592913095941130959421309595513095957130960331309603413096037130960381309604013096063130960641309606513096120130961281309614513096151130961551309616213096173130961931309619513096200130962061309621213096217130962181309622013096223130962241309622713096230
- Amount recalled
- 211 devices
Where it was sold
Why it was recalled
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
This product could cause temporary or reversible health problems — stop using it.
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