Events

Rappel de Device Recall FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner (FDR1000BPY)

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
    74525
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2690-2016
  • Date de mise en oeuvre de l'événement
    2016-06-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147840
  • 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
    If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
  • Action
    The firm, Fujifilm, sent a "FIELD SAFETY NOTICE" letter dated June 9, 2016 via Federal Express to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to read and follow the instructions in the letter; call your local service representative, in case an error occurs, and complete and return the Customer Feedback Form via fax (203)-251-7862. Both affected systems will be corrected via on-site visits by FMSU Customer Service Engineers. If you have any questions about this matter, please contact the Product Manager, Women's Health directly at (303)-888-4549 or call your local FUJIFILM office.

Device

Device Recall FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner ...
  • Modèle / numéro de série
    26330437 and 17230408
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to: NC and HI.
  • Description du dispositif
    FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) || The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), 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