Events

Recall of OEC 7600 Mobile Fluoroscopy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE OEC Medical Systems, 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
    46349
  • Event Risk Class
    Class 2
  • Event Number
    Z-0716-2008
  • Event Date Posted
    2008-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67221
  • 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
    Mobile Fluoroscopy X-Ray System - Product Code JAA
  • Reason
    Unnecessary operator exposure; x-ray machine may allow unwanted x-ray exposure to the operator.
  • Action
    On or about 9/6/2007, by Customer Notification Letter, users were notified that all affected units will be corrected by GE personnel with the addition of an additional shield.

Device

OEC 7600 Mobile Fluoroscopy System
  • Model / Serial
    All Serial Numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide- USA including states of CO, DE, FL, NJ, MO, NY, PA, and TX (with VA and Military facilities) and countries of Australia, Austria, Belgium, Brazil, Chile, China, The Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Spain, Sweden, Switzerland, Thailand, and The UK.
  • Product Description
    GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA