Events

Recall of Device Recall Fujufilm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fujifilm Medical System USA, 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
    26390
  • Event Risk Class
    Class 2
  • Event Number
    Z-0932-03
  • Event Initiated Date
    2003-05-12
  • Event Date Posted
    2003-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27603
  • 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
    System, Image Processing, Radiological - Product Code LLZ
  • Reason
    Synapse version 2.2.1 and 2.3.1 software [free-hand region] may lead to incorrect density calculations during ct scan.
  • Action
    FujiFilm notified users via letter notification during the week of May 12, 2003. Users wll be visited by a Regional Service Engineer to install the corrected software.

Device

Device Recall Fujufilm
  • Model / Serial
    Verson 2.2.1 and 2.3.1.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada, Germany, Israel, Japan
  • Product Description
    Synapse Version 2.2.1 and 2.3.1 software
  • Manufacturer
    Fujifilm Medical System USA, Inc.

Manufacturer

Fujifilm Medical System USA, Inc.
  • Manufacturer Address
    Fujifilm Medical System USA, Inc., 419 West Avenue, Stamford CT 06902
  • Source
    USFDA