KaVo Dental Technologies LLC: 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.

Recall number

Z-1387-2019

Recalling firm

KaVo Dental Technologies LLC

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.

Status

Terminated

Initiated

2019-04-29

Posted

not on file

Terminated

2020-11-25

Reason

The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.

Root cause

Device Design

Action

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

Quantity

211 devices

Distribution

Worldwide Distribution - US Nationwide to AL, AR, AZ, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, OH, OK, PA, TN, TX, VA, WA, WI, WV and internationally to Canada.

Lot, serial or model codes

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.

510(k) numbers

["K172918"]

PMA numbers

not on file

Product code

MUH

Firm FEI

1017522

Firm city

Charlotte

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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