Class 2 Device Recall DEXIS Titanium Intraoral Sensor

• Date Initiated by Firm: April 29, 2019
• Create Date: May 21, 2019
• Recall Status: Terminated on November 25, 2020
• Recall Number: Z-1387-2019
• Recall Event ID: 82694
• 510(K)Number: K172918
• Product Classification: System, x-ray, extraoral source, digital - Product Code MUH
• 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: KaVo Dental Technologies LLC; 11727 Fruehauf Dr; Charlotte NC 28273-6507
• For Additional Information Contact: Sharon Miles; 704-917-0678
• Manufacturer Reason for Recall: The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MUH