DEXIS Titanium Sensor (KaVo) – Image Quality Reduction (2019)
Incorrectly programmed calibration files can reduce dental imaging quality.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
KaVo Dental Technologies LLC
Lot Codes / Batch Numbers
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, 13095823, 13095827, 13095839, 13095876, 13095890, 13095897, 13095899, 13095900, 13095921, 13095927, 13095929, 13095941, 13095942, 13095955, 13095957, 13096033, 13096034, 13096037, 13096038, 13096040, 13096063, 13096064, 13096065, 13096120, 13096128, 13096145, 13096151, 13096155, 13096162, 13096173, 13096193, 13096195, 13096200, 13096206, 13096212, 13096217, 13096218, 13096220, 13096223, 13096224, 13096227, 13096230, 13096234, 13096235, 13096244, 13096252, 13096257, 13096267, 13096272, 13096286, 13096290, 13096292, 13096295, 13096299, 13096311, 13096318, 13096322, 13096335, 13096340, 13096344, 13096346, 13096348, 13096355, 13096362, 13096383, 13096391, 13096402, 13096405, 13096410, 13096417, 13096426, 13096428, 13096430, 13096437, 13096439, 13096466, 13096479, 13096483, 13096490, 13096491, 13096504, 13096505, 13096518, 13096527, 13096564, 13096574, 13096576, 13096580, 13096583, 13096591, 13096593, 13096602, 13096610, 13096622, 13096725, 13096738, 13096760, 13096804, 13096825, 13096831, 13096883, 13096905, 13096916, 13096928, 13096947, 13096958, 13096960, 13096964, 13096968, 13096970, 13096975, 13096979, 13096982, 13096984, 13096993, 13097017, 13097018, 13097038, 13097039, 13097101, 13097109, 13097118, 13097121, 13097126, 13097153, 13097166, 13097170, 13097181, 13097190, 13097193, 13097195, 13097199, 13097211, 13097214, 13097217, 13097234, 13097240, 13097241, 13097247, 13097249, 13097252, 13097269, 13097287, 13097299, 13097306, 13097309, 13097320, 13097322, 13097326, 13097348, 13097386, 13097389, 13097398, 13097418, 13097419, 13097422, 13097438, 13097439, 13097464, 13097469, 13097476, 13097478, 13097503, 13097517, 13097518, 13097532, 13097546, 13097553, 13097554, 13097557, 13097559, 13097562, 13097580, 13097584, 13097589, 13097603, 13097615, 13097616, 13097619, 13097808, 13097827, 13097838, 13095874, 13095917, 13095930, 13096057, 13096240, 13096448, 13097145, 13097230, 13097245, 13097463, 13097813.
Products Sold
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, 13095823, 13095827, 13095839, 13095876, 13095890, 13095897, 13095899, 13095900, 13095921, 13095927, 13095929, 13095941, 13095942, 13095955, 13095957, 13096033, 13096034, 13096037, 13096038, 13096040, 13096063, 13096064, 13096065, 13096120, 13096128, 13096145, 13096151, 13096155, 13096162, 13096173, 13096193, 13096195, 13096200, 13096206, 13096212, 13096217, 13096218, 13096220, 13096223, 13096224, 13096227, 13096230, 13096234, 13096235, 13096244, 13096252, 13096257, 13096267, 13096272, 13096286, 13096290, 13096292, 13096295, 13096299, 13096311, 13096318, 13096322, 13096335, 13096340, 13096344, 13096346, 13096348, 13096355, 13096362, 13096383, 13096391, 13096402, 13096405, 13096410, 13096417, 13096426, 13096428, 13096430, 13096437, 13096439, 13096466, 13096479, 13096483, 13096490, 13096491, 13096504, 13096505, 13096518, 13096527, 13096564, 13096574, 13096576, 13096580, 13096583, 13096591, 13096593, 13096602, 13096610, 13096622, 13096725, 13096738, 13096760, 13096804, 13096825, 13096831, 13096883, 13096905, 13096916, 13096928, 13096947, 13096958, 13096960, 13096964, 13096968, 13096970, 13096975, 13096979, 13096982, 13096984, 13096993, 13097017, 13097018, 13097038, 13097039, 13097101, 13097109, 13097118, 13097121, 13097126, 13097153, 13097166, 13097170, 13097181, 13097190, 13097193, 13097195, 13097199, 13097211, 13097214, 13097217, 13097234, 13097240, 13097241, 13097247, 13097249, 13097252, 13097269, 13097287, 13097299, 13097306, 13097309, 13097320, 13097322, 13097326, 13097348, 13097386, 13097389, 13097398, 13097418, 13097419, 13097422, 13097438, 13097439, 13097464, 13097469, 13097476, 13097478, 13097503, 13097517, 13097518, 13097532, 13097546, 13097553, 13097554, 13097557, 13097559, 13097562, 13097580, 13097584, 13097589, 13097603, 13097615, 13097616, 13097619, 13097808, 13097827, 13097838, 13095874, 13095917, 13095930, 13096057, 13096240, 13096448, 13097145, 13097230, 13097245, 13097463, 13097813.
KaVo Dental Technologies LLC is recalling DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driv due to The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
Recommended Action
Per FDA guidance
KaVo Dental Technologies, LLC notified customers on about 04/29/2019, via "URGENT: MEDICAL DEVICE RECALL - CORRECTION" letter. Customers were instructed to: 1.) Review the serial number information included with this letter and identify where the affected devices are located in your facility; 2.) For any affected devices that are installed, stop usage and contact Customer Care at 1-888-883-3947 (Option 1) to start the correction via remote connection. See Supplemental Directions on Page 2; 3.) For any affected devices that are unopened or uninstalled, return them to KaVo Dental Technologies, LLC. See Supplemental Directions on Page 2; 4.) If you have sold or forwarded the affected devices to a location outside your control, see Supplemental Directions on Page 2; 5.) Your response is required: Complete and sign the bottom portion of this letter. Return a copy of completed and signed Page 1 to confirm your Recall Responsibility is complete. Note: This can be completed by dental office personnel or on your behalf by your Authorized Dealer. Correction via Reprogramming by a Customer Care Representative: 1.) If you would like to complete your Recall Responsibility by a correction of any affected devices that are already installed, this can be completed free of charge by a Customer Care Representative via remote connection. 2.) The issue can be resolved through a simple and brief software reprogramming activity by replacing the calibration correction file through a remote connection. The sensor hardware meets all specifications, and following the software reprogramming activity, the sensor will operate as intended. 3.) To begin, please contact Customer Care at 1-888-883-3947 (Option 1). 4.) The Customer Care Representative will provide instructions on how to complete the software correction via remote connection. 5.) However, if you prefer to return your affected devices that are installed instead of remote connection, follow the return direction
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026