Events

Rappel de FullField Digital Mammography 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 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
    79078
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0661-2018
  • Date de mise en oeuvre de l'événement
    2017-08-04
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161292
  • 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
    Full field digital,system,x-ray,mammographic - Product Code MUE
  • Cause
    Fujifilm medical systems u.S.A., inc. (fmsu) identified a potential failure with our mammography system. the acquisition workstations, fdr¿1000aws, fdr-2000aws, fdr-3000aws, and cr¿ir363aws assign a unique id number to every image study but very rarely, with the acquisition workstation software versions, vs.O, vs.1, vs.2 , v6.0, v6.1, and v7.0, the system may assign the same id number to a new set of images that was already assigned to the previous set of images due to the error in id number generation logic. if an image with this error (with duplicate id number) is transmitted to pacs, it may overwrite the image already stored on pacs.
  • Action
    The firm, FUJIFILM Medical Systems U.S.A., Inc. (FMSU), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 7/28/2017 to its customers. The letter described the products, problem and actions to be taken. The customers were instructed to please read and follow the instructions in the "ACTIONS TO BE TAKEN BY CUSTOMER/USER" section. If you have an error, contact your local FUJIFILM office; and complete and return the Customer Feedback Form. FUJIFILM service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures.. If you have any questions about this matter, call Recall contact (203) 276-3445 or email: dharaben.desai@fujifilm.com.

Device

FullField Digital Mammography Xray System
  • Modèle / numéro de série
    3000AWS. Released Software Versions: V5.1, V5.2, V6.0, V6.1, V7.0. Not Released Software Versions: V5.0.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    ASPIRE Cristalle (for FDR-3000AWS) || The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
  • 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., 419 West Ave, Stamford CT 06902-6343
  • Société-mère du fabricant (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA