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Recall Observatory FDA recall evidence

Device 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.

Z-1387-2019

April 29, 2019

Class II

Product summary

Firm
KaVo Dental Technologies LLC
Event
Event 82694
Status
Terminated
Classification
Class II
Quantity
211 devices
Official record key
device-enforcement:Z-1387-2019

Official wording

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

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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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