Events

Rappel de Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope

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 Integrated Medical Systems Inc.

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
    73088
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0891-2016
  • Date de mise en oeuvre de l'événement
    2016-01-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143125
  • 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
    Endoscope, flexible - Product Code GCQ
  • Cause
    If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
  • Action
    The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes.

Device

Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope
  • Modèle / numéro de série
    Serial Numbers: 2601800,2807942,2104002,2807968,2003519,2003522,2003506,2003533,2003517,2807849, 2807869,2106004,2001560,2602147,2806411,2900360,2001561,2602228,2602229,2309559, 2309556,2602230,2805615,2103724,2103717,2002975,2805586,2806264,2806591,2705038, 2908746,2808043,2704335,2705017,2002983,2106012,2105987,2106009,2106019,2002580, 2002571,2104510,2002603,2900105,2001677,2105162,2909901,2703303,2909972,2601007, 2601084,2104893,2704419,2806374,2806356,2104903,2908799,2601095,2807327,2640009, 2702843,2207664,2207660,2702782,2106428,2806318,2908674,2702730,2704143,2703560, 2106031,2908845,2908846,2908841,2908838,2908852,2908837,2908840,2908843,2106106, 2601525,2807589,2808233,2309810,2805782,2909109,2601535,2104776,2104781,2806163, 2908908,2103829,2104924,2002427,2909718,2002323,2703941,2601588,2601200,2600263, 2309366,2602033,2602034,2900148,2106202,2003379,2000851,2003280,2106797,2003653, 2106800,2807548,2106791,2909657,2003008,2003228,2003232,2106134,2808000,2900241, 2900656,2000774,2106423,2003189,2106410,2309513,2900683,2106413,2807888,2309493, 2106264,2106409,2106422,2107166,2909809,2107149,2808271,2702536,2702344,2704544, 2704568,2704587,2703158,2104281,2703144,2602024,2002832,2805717,2002833,2600272, 2704020,2001762,2207531,2900586,2003128,2208594,2002620,2309683,2001688,2104750, 2104891,2309573,2000881,2309635,2001645,2001650,2106010,2104981,2104993,2104937, 2104890,2900413,2703200,2601190,2309828,2909966,2601218,2001712,2601205,2806343, 2704399,2704716,2105584,2105562,2105559,2104847,2601672,2601642,2602223,2808051, 2703078,2002521,2601938,2601866,2908548,2908499,2105744,2909315,2105988,2106017, 2309497,2309262,2104662,2806423,2105002,2105542,2001423,2309783,2703663,2703654, 2001547,2600215,2001708,2001468,2001514,2001519,2309845,2001311,2309105,2208046, 2208058,2806987,2704187,2208651,2309470,2003116,2003086,2003104,2208215,2001850, 2805888,2309542
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed US (nationwide) and in Australia.
  • Description du dispositif
    Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope
  • Manufacturer
    Integrated Medical Systems Inc

Manufacturer

Integrated Medical Systems Inc
  • Adresse du fabricant
    Integrated Medical Systems Inc, 3200 2nd Ave N, Birmingham AL 35222-1212
  • Société-mère du fabricant (2017)
    Integrated Medical Systems Inc.
  • Source
    USFDA