Events

Recall of Device Recall Fujifilm

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
    34652
  • Event Risk Class
    Class 2
  • Event Number
    Z-0622-06
  • Event Initiated Date
    2006-02-03
  • Event Date Posted
    2006-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44379
  • 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
    Image orientation and orientation markers may not match when an image is rotated or flipped when the ct image is preset.
  • Action
    FujiFilm Medical Systems USA notified users by letter dated 2/3/06. Users are requested to deactivate the CT Image Processing functionality SWAT (Synapse Web Administration Tool).

Device

Device Recall Fujifilm
  • Model / Serial
    Versions 3.1.0 and 3.1.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada, Japan, Germany
  • Product Description
    Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS
  • Manufacturer
    Fujifilm Medical System USA, Inc.

Manufacturer

Fujifilm Medical System USA, Inc.
  • Manufacturer Address
    Fujifilm Medical System USA, Inc., 419 West Ave, Stamford CT 06902-6300
  • Source
    USFDA