Events

Rappel de Device Recall Orthoralix 8500 DDE Panoramic Dental XRay System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Gendex Dental Systems.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57502
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1373-2011
  • Date de mise en oeuvre de l'événement
    2010-12-21
  • Date de publication de l'événement
    2011-02-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96394
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Unit, x-ray, extraoral with timer - Product Code EHD
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Gendex Dental Systems, 901 W Oakton St, Des Plaines IL 60018-1843
  • Source
    USFDA