Events

Rappel de Device Recall FUJINON ED530XT

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
    78065
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3225-2017
  • Date de mise en oeuvre de l'événement
    2017-07-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158600
  • 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
    An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. the action includes replacement of the forceps elevator mechanism, the o-ring seal, the distal end cap and issuance of a new operation manual.
  • Action
    On July 21, 2017, Fujifilm Medical Systems U.S.A., Inc. Endoscopy Division distributed Urgent Medical Device Correction and Removal notices & Field Action Verification Forms to their U.S. Consignees by USPS certified mail. Fujifilm Medical Systems will contact all customers that have the duodenoscope by October 2017, with details for returning the device for replacement parts. This field action allows continued use of the current device until you are contacted by a sales representative for replacement parts as early as October 2017. While the remediation of the scopes will take approximately two weeks to complete, Fujifilm Medical Systems U.S.A. Inc. Endoscopy Division will provide interim duodenoscopes on loan for continuity of care. Once received, the recalling firm will replace the forceps elevator mechanism with O-ring and the distal end cap. An updated manual has been generated to include new information/guidance. Customers are encouraged to complete and return the Field Action Verification Form via email to fnonmedicalqa@fujifilm.com or via fax to (973) 872-4723. Customers with questions can call Larry Picciano, Sr. Director Quality and Regulatory Affairs at (973) 686-2479.

Device

Device Recall FUJINON ED530XT
  • Modèle / numéro de série
    All lots/serial numbers
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    FUJINON ED-530XT. || This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
  • 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