Events

Recall of Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1.

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
    30206
  • Event Risk Class
    Class 2
  • Event Number
    Z-0055-05
  • Event Date Posted
    2004-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35396
  • 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
    Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
  • Reason
    Genital protector shield used with fuji computed radiography (fcr) system models 5501d and xu/d1. model: gp344 may detach from the mounting block and fall during use.
  • Action
    Fuji are notifying users through Fuji service representatives who are hand delivering the notfication letter dated 9/30/04 and installing the mandatory hardware upgrade.

Device

Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1.
  • Model / Serial
    All lots
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CO, CT, NY, MD, MI, MN, NV, UT
  • Product Description
    Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. || Model: GP344
  • 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