Events

Rappel de Device Recall Pentax Medical

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 Pentax Medical Company.

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
    73377
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1835-2016
  • Date de mise en oeuvre de l'événement
    2016-02-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-12-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143988
  • 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
    duodenoscope and accessories, flexible/rigid - Product Code FDT
  • Cause
    Pentax medical learned of reports of carbapenem-resistant enterobacteriaceae (cre) infection at a medical facility.
  • Action
    Pentax Inc. issued an "Urgent Field Correction" Letter dated February 19, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter provides information regarding the updated Reprocessing instruction for use along with some main changes in the Operation IFU. Instructions are also provided regarding prior versions of the Reprocessing and Operation Instructions for Use. A web posting went live on 2/19/2016. For further questions, please call: Tel:800-431-5880 ext. 2064 (8:30AM- 5:00 PM, Monday-Friday, EST)

Device

Device Recall Pentax Medical
  • Modèle / numéro de série
    A110021, A110022, A110023, A110024, A110025, A110026, A110027, A110028, A110029, A110030, A110031, A110032, A110033, A110034, A110035, A110036, A110037, A110038, A110039, A110043, A110046, A110051, A110055, A110056, A110057, A110058, A110059, A110060, A110061, A110062, A110063, A110064, A110065, A110067, A110068, A110070, A110071, A110072, A110073, A110074, A110075, A110076, A110077, A110078, A110079, A110080, A110081, A110082, A110083, A110086, A110087, A110088, A110089, A110090, A110091, A110092, A110095, A110098, A110099, A110100, A110114, A110115, A110116, A110117, A110118, A110121, A110122, A110127, A110128, A110129, A110130, A110131, A110132, A110133, A110134, A110135, A110136, A110137, A110138, A110140, A110142, A110143, A110150, A110152, A110156, A110157, A110158, A110159, A110160, A110162, A110163, A110164, A110165, A110166, A110167, A110168, A110169, A110170, A110173, A110174, A110177, A110178, A110179, A110180, A110182, A110183, A110190, A110191, A110192, A110193, A110194, A110203, A110204, A110206, A110207, A110208, A110209, A110210, A110211, A110213, A110214, A110215, A110216, A110217, A110218, A110229, A110230, A110231, A110232, A110233, A110234, A110235, A110236, A110237, A110243, A110244, A110246, A110247, A110248, A110249, A110250, A110251, A110252, A110258, A110259, A110260, A110268, A110269, A110272, A110273, A110274, A110275, A110276, A110277, A110278, A110279, A110280, A110281, A110283, A110284, A110285, A110287, A110288, A110289, A110290, A110293, A110297, A110301, A110302, A110304, A110305, A110306, A110307, A110308, A110316, A110317, A110318, A110319, A110320, A110321, A110322, A110323, A110324, A110325, A110326, A110327, A110328, A110329, A110331, A110333, A110338, A110339, A110345, A110347, A110352, A110362, A110363, A110385, A110386, A110387, A110388, A110389, A110390, A110391, A110392, A110393, A110399, A110403, A110405, A110406, A110407, A110409, A110410, A110412, A110413, A110415, A110416, A110417, A110418, A110419, A110421, A110422, A110424, A110438, A110439, A110440, A110454, A110462, A110464, A110466, A110468, A110470, A110473, A110474, A110476, A110480, A110483, A110491, A110492, A110495, A110496, A110497, A110498, A110499, A110501, A110502, A110518, A110520, A110521, A110524, A110525, A110527, A110534, A110535, A110538, A110547, A110549, A110550, A110553, A110554, A110555, A110574, A110581, A110582, A110587, A110588, A110589, A110590, A110591, A110593, A110594, A110595, A110596, A110598, A110599, A110600, A110601, A110602, A110607, A110610, A110612, A110614, A110615, A110616, A110617, A110619, A110620, A110621, A110623, A110625, A110626, A110633, A110649, A110651, A110652, A110654, A110665, A110666, A110667, A110668, A110669, A110670, A110671, A110672, A110674, A110675, A110676, A110677, A110678, A110680, A110682, A110683, A110684, A110686, A110692, A110694, A110695, H110699, H110700, H110701, H110703, H110704, H110705, H110706, H110707, H110708, H110709, H110710, H110711, H110712, H110714, H110715, H110716, H110717, H110718, H110719, H110721, H110723, H110729, H110733, H110736, H110737, H110738, H110740, H110749, H110754, H110767, H110773, H110774, H110775, H110779, H110780, H110781, H110782, H110783, H110784, H110786, H110788, H110789, H110790, H110791, H110792, H110793, H110794, H110795, H110796, H110797, H110799, H110800, H110802, H110803, H110805, H110807, H110819, H110822, H110823, H110825, H110826, H110827, H110828, H110830, H110831, H110832, H110834, H110835, H110837, H110838, H110840, H110842, H110844, H110845, H110846, H110849, H110850, H110851, H110852, H110853, H110858, H110859, H110860, H110861, H110862, H110863, H110865, H110866, H110867, H110868, H110869, H110870, H110871, H110872, H110873, H110876, H110877, H110880, H110881, H110882, H110883, H110890, H110891, H110892, H110893, H110894
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Video Duodenoscope
  • Manufacturer
    Pentax Medical Company

Manufacturer

Pentax Medical Company
  • Adresse du fabricant
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • Société-mère du fabricant (2017)
    HOYA Corp.
  • Source
    USFDA