Events

Recall of Electrophysiology Imaging 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
    31930
  • Event Risk Class
    Class 2
  • Event Number
    Z-1527-05
  • Event Initiated Date
    2005-04-28
  • Event Date Posted
    2005-09-09
  • 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=41637
  • 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, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
  • Reason
    Belt driving the image intensifier may break, causing the intensifier to slip down, possibly causing injury to patient.
  • Action
    Consignees were notified by certified letter on 04/27/2005.

Device

Electrophysiology Imaging System
  • Model / Serial
    Model EPX-60, Product Number 105375G
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
  • Product Description
    Electrophysiology Imaging System
  • Manufacturer
    Fischer Imaging Corporation

Manufacturer

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