Events

Rappel de Device Recall Dudenoscope

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 Fujifilm Medical Systems U.S.A., 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
    72258
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0418-2016
  • Date de mise en oeuvre de l'événement
    2015-08-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-03-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140362
  • 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
    A precautionary measure because the duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
  • Action
    FujiFilm mailed a Medical Device Recall Letter and Tracking/Verification Form dated August 31, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to check their inventory for affected product, if found, affected product should be removed from circulation and returned to Fugifilm. Customers were also asked to complete and return the enclosed tracking/verification form to Fujifilm Medical Systems USA, Inc., Endoscopy Division (FMSU-ESD), 10 High Point Drive, Wayne, NJ 07470 or via fax to 973-633-8818. Customers with questions were instructed to contact their Fujifilm sales representative. For questions regarding this recall call 973-686-2482

Device

Device Recall Dudenoscope
  • Modèle / numéro de série
    Model Number: ED-200XU: Serial Numbers: 6572042, 5511033 and H451107  Model Number: ED-200XT: Serial Number: 8681034  Model Number: ED-250XT: Serial Number: HD077A008  Model Number: ED-310XU: Serial Number: 8591013  Model Number: ED-420XL: Serial Numbers: 9711002, 2D071D016, 2D071D010, 2D071D029 and 2D071D026  Model Number: ED-410XT: Serial Numbers: 8691039, 8691034 and 7691022  Model Number: ED-410XU: Serial Numbers: 2D060D010, 2D060D003, 6602091 and 6602100  Model Number: ED-450XL: Serial Numbers: 6D075B023, 6D075B015, 1D075B029 and 6D075B020  Model Number: ED-450XT: Serial Numbers; 1D076A002, 1D076A011, 1D076A013, 1D076A043, 1D076A039, 6D076A020, 6D076A033, 6D076A039, 6D076A037, 6D076A030 and 6D076A051
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US including CA, CO, FL, IA, IL, KS, LA, MD, MN, MO, NC, TN and WA and Internationally to Asian Pacific, EU, Latin America, and Japan.
  • Description du dispositif
    Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.
  • Adresse du fabricant
    Fujifilm Medical Systems U.S.A., Inc., 10 Highpoint Dr, Wayne NJ 07470-7431
  • Société-mère du fabricant (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA