Device Recall Orthoralix 8500 DDE Panoramic Dental XRay System

  • Modelo / Serial
    a) North American units manufactured between 12/4/09 and 5/16/10 and had a working AEC button, but the manual stated that it was disabled: serial numbers 1863844, 1950710, 1950714, 1954576, 1954577, 1954578, 1954579, 1954581, 1954582, 1954583, 1954584, 1954585, 1954587, 1954589, 1954590, 1954591, 1954593, 1954598, 1954599, 1954600, 1954601, 1954603, 1954605, 1954606, 1954607, 1954614, 1954616, 1954617, 1954618, 1954619, 1954622, 1954623, 1954625, 1954626, 1954627, 1954628, 1954629, 1954630, 1954631, 1954632, 1954633, 1954634, 1954635, 1954637, 1954638, 1954639, 1954640, 1954641, 1954642, 1954643, 1954644, 1954645, 1954646, 1954647, 1954648, 1954649, 1954650, 1954651, 1954652, 1954653, 1954654, 1954656, 1954657, 1954658, 1954659, 1954660, 1954661, 1954662, 1954664, 1954665, 1954666, 1954667, 1954668, 1954669, 1954670, 1954673, 1954674, 1954675, 1957474, 1957926, 1957927, 1957929, 1957930, 1957931, 1957932, 1957933, 1957934, 1957935, 1957936, 1957937, 1957940, 1957941, 1957942, 1957943, 1957944, 1957945, 1957946, 1957947, 1957948, 1957949, 1957950, 1957951, 1957952, 1957953, 1957955, 1957956, 1957959, 1957960, 1957963, 1957966, 1957967, 1957968, 1957973, 1957977, 1957978, 1957980, 1957982, 1957983, 1957983, 1957986, 1957987, 1957988, 1957989, 1957991, 1957994, 1957997, 1957998, 1957999, 1958000, 1958003, 1958004, 1958005, 1958006, 1958007, 1958010, 1958011, 1958012, 1958013, 1958014, 1958015, 1958016, 1958017, 1958018, 1958020, 1958021, 1958022, 1958024, 1958025, 1960071, 1960072, 1960073, 1960074, 1961209, 1961210, 1961218, 1961219, 1961226, 1961231, 1961233, 1961234, 1961236, 1961237, 1961243, 1961244, 1961246, 1961247, 1961248, 1961250, 1961253, 1961255, 1961256, 1961257, 1961258, 1961261, 1961263, 1961264, 1961267, 1961268, 1961269, 1961270, 1961271, 1961272, 1961273, 1961274, 1961275, 1961279, 1961280, 1961283, 1961288, 1961289, 1961290, 1961291, 1961293, 1961294, 1961296, 1961298, 1961299, 1961300, 1961306, 1961307, 1963607, 1963608, 1963611, 1963712, 1963713, 1963714, 1963716, 1963717, 1963718, 1963719, 1963720, 1963721, 1963722, 1963725, 1963726, 1963735, 1963737, 1963738, 1963739, 1963740, 1963741, 1963742, 1963743, 1963744, 1963745, 1963746, 1963747, 1963753, 1963756, 1963758, 1963759, 1963760, 1963766, 1963776, 1963810, 1963812, 1963813, 1963814, 1963816, 1963818, 1963819, 1963820, 1963821, 1963822, 1963823, 1963825, 1963826, 1963827, 1963828, 1963830, 1963831, 1963832, 1963833, 1963835, 1963836, 1963837, 1963838, 1963839, 1963840, 1963842, 1963843, 1963848, 1963849, 1963852, 1963853, 1963855, 1963858, 1963860, 1963876, 1963879, 1963883, 1963886, 1963887, 1963888, 1963895, 1963896, 1963898, 1963899, 1963900, 1963902, 1963904, 1963906, 1963909, 1963910, 1964843, 1964845, 1964846, 1970570, 1970571, 1970572, 1970575, 1970576, 1970577, 1970578, 1970580, 1970583, 1970587, 1970606, 1970608, 1970611, 1970612, 1970613, 1970614, 1970615, 1970618, 1970620, 1970621, 1970622, 1970624, 1970625, 1970627, 1970628, 1970629, 1970630, 1970631, 1970632, 1970634, 1970635 and 1970636;  b) units manufactured between 5/17/10 and 11/9/10 and had a disabled AEC button, but the English section of the international manual stated that it was functional: serial numbers 1957969, 1957971, 1957974, 1961227, 1961228, 1961260, 1961262, 1961276, 1961278, 1961282, 1961284, 1961285, 1961292, 1961302, 1961303, 1961304, 1961305, 1963723, 1963727, 1963729, 1963750, 1963751, 1963752, 1963754, 1963755, 1963757, 1963762, 1963763, 1963765, 1963767, 1963768, 1963769, 1963774, 1963778, 1963782, 1963783, 1963784, 1963785, 1963788, 1963789, 1963790, 1963791, 1963792, 1963794, 1963795, 1963796, 1963800,  1963803, 1963804, 1963806, 1963808, 1963809, 1963815, 1963861, 1963862, 1963864, 1963870, 1963871, 1963872, 1963877, 1963882, 1963884, 1963894, 1963897, 1963908, 1970568, 1970569, 1970573, 1970574, 1970584, 1970586, 1970589, 1970591, 1970594, 1970595, 1970597, 1970598, 1970599, 1970600, 1970601, 1970603, 1970610, 1970616, 1970619, 1970623 and 1970626;  c) units manufactured between 5/17/10 and 11/9/10 and had a disabled AEC button, but the French, German, Italian and Spanish sections of the international manual stated that it was functional: serial numbers 1970638, 1970639, 1970640, 1970641, 1970643, 1970645, 1970649, 1970650, 1970651, 1970652, 1970653, 1970654, 1970663, 1970664, 1973813,  1973814, 1973817, 1973820, 1973824, 1973828, 1973834, 1973848, 1973849, 1973850, 1973851, 1973857, 1973858, 1973878, 1973885, 1973887, 1973889, 1973891, 1973893, 1974792, 1976592, 1976594, 1976598, 1976611, 1976614, 1976619, 1976634, 1976637, 1976638, 1978213, 1978217, 1978221, 1978228, 1978233, 1978252, 1978253, 1978254, 1978255, 1978258, 1978264, 1978265, 1978266, 1978268,  1978269, 1978271, 1978278, 1978279, 1978280, 1978284, 1978285, 1978287, 1978288, 1978289, 1978290, 1978291, 1978292, 1978294, 1978295, 1978296, 1978297, 1978298, 1978299, 1978300, 1978301, 1978302, 1978306, 1978307, 1978308, 1978340, 1978341, 1978342, 1978346, 1978348, 1978350, 1982523, 1982543, 1982552, 1982553, 1982554, 1982561, 1982567, 1982570, 1982571, 1982572, 1982573,  1982575, 1982576, 1982577, 1982578, 1982580, 1982581, 1982582, 1982588, 1982589, 1982590, 1982591, 1982592, 1982593, 1982595, 1982596, 1982597, 1982598, 1982599, 1982601, 1982604, 1982607, 1982608, 1982609, 1982612, 1982614, 1982615, 1982616, 1982617, 1982618, 1982619, 1982621, 1982622, 1982624, 1982625, 1982628, 1982629, 1982631, 1982632, 1982633, 1982634, 1982714, 1982716,  1989268, 1989272, 1989275, 1989276, 1989278, 1989281, 1989293, 1989294, 1989295, 1989298, 1989303, 1989306, 1989307, 1989314, 1989315, 1989316, 1989328, 1989331, 1989339, 1989340, 1989389, 1989395, 1989396, 1989400, 1989401, 1989403, 1989406 and 1989407
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WA, and WI and the countries of Australia, Canada, Germany, New Zealand, Taiwan, and Vietnam.
  • Descripción del producto
    Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international) || The Orthoralix 8500 DDE Panoramic Dental X-Ray System is used as an extraoral source of x-rays for imaging of the dento-maxillofacial area.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Gendex Dental Systems, 901 W Oakton St, Des Plaines IL 60018-1843
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3 and all serial numbers .
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam.
  • Descripción del producto
    Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. || The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.
  • Manufacturer