Events

Retiro De Equipo (Recall) de Device Recall Orthoralix 8500 DDE Panoramic Dental XRay System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Gendex Dental Systems.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57502
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1373-2011
  • Fecha de inicio del evento
    2010-12-21
  • Fecha de publicación del evento
    2011-02-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96394
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Unit, x-ray, extraoral with timer - Product Code EHD
  • Causa
    The automatic exposure control (aec) feature located on the control panel of the orthoralix 8500 panoramic dental x-ray system was functional, but was subsequently disabled in units manufactured starting 5/17/10. north american units manufactured between 12/4/09 and 5/16/10 had functioning aec buttons, but their manuals stated they were disabled. units intended for international distribution bet.
  • Acción
    Gendex sent a recall letter to their accounts on December 21, 2010, stating that the AEC button on the control panel was a non-functional feature that becomes illuminated upon activation and that Gendex would send them a kit to correct this issue and inactivate the button. A second letter was sent to the accounts on January 31, 2011, explaining that a corrective kit was no longer necessary, letting them know if the AEC feature was active or inactive for their system, and providing them with the appropriate user manual addendum for their system. Customers were asked to complete and return the required Acknowledgement Form by fax to 215-997-5665 or e-mail: regulatoryaffairs@gendex.com. For questions regarding this recall call 800-323-8029.

Device

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
    Radiology Devices
  • 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
    Gendex Dental Systems

Manufacturer

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