Events

Recall of Device Recall Fujifilm Aspire HD, Full Field Digital, System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fujifilm Medical Systems U.S.A., Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70854
  • Event Risk Class
    Class 2
  • Event Number
    Z-1585-2015
  • Event Initiated Date
    2015-02-03
  • Event Date Posted
    2015-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135198
  • Notes / Alerts
    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.
  • Extra notes in the data
    Full field digital,system,x-ray,mammographic - Product Code MUE
  • Reason
    User manual lacks a description for handling some errors even though the system can be recovered from such errors.
  • Action
    Fuji Film on 2/3/15, issued a User Notification letter and the recovery procedure were hand carried to the user. A copy of Notification Letter is user's acknowledgement of receipt of the manual .

Device

Device Recall Fujifilm Aspire HD, Full Field Digital, System
  • Model / Serial
    Serial Number: 26320119
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in HI.
  • Product Description
    Aspire HD, Full Field Digital, System, x-Ray, Mammographic; || Model: FOR MS-1000. || A mammography system used for screening and diagnosis of breast cancer.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.
  • Manufacturer Address
    Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA