Events

Recall of General Radiographic System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fischer Imaging Corporation.

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
    28995
  • Event Risk Class
    Class 2
  • Event Number
    Z-0974-04
  • Event Initiated Date
    2004-04-23
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32940
  • 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
    Tube Mount, X-Ray, Diagnostic - Product Code IYB
  • Reason
    If two of the four t-nuts that connect the transverse rail to the ceiling rail fail, the 'u' arm and transverse rails could fall and cause serious injury.
  • Action
    Consignees were notified by letter on 4/23/2004.

Device

General Radiographic System
  • Model / Serial
    All units.
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in MI, MN and VT. No military consignees. Foreign distribution to Australia, Canada, Denmark, Italy, Korea, Netherlands, Norway, Sweden, United Kingdom.
  • Product Description
    VersaRad/Traumex General Radiographic System.
  • Manufacturer
    Fischer Imaging Corporation

Manufacturer

Fischer Imaging Corporation
  • Manufacturer Address
    Fischer Imaging Corporation, 12300 Grant St, Denver CO 80241-3120
  • Source
    USFDA