Z-1387-2019 Class II Terminated
FDA device recall Z-1387-2019 was initiated by KaVo Dental Technologies LLC on April 29, 2019 and is designated Class II. Reason for recall: The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality. The recall status is terminated (terminated November 25, 2020). Affected quantity: 211 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- April 29, 2019
- Termination Date
- November 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 211 devices
Product Description
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.
Reason for Recall
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
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.
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.