Events

Recall of Device Recall OEC 9900

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    49536
  • Event Risk Class
    Class 2
  • Event Number
    Z-0368-2008
  • Event Initiated Date
    2007-12-14
  • Event Date Posted
    2008-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73760
  • 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
    fluoroscopic x-ray system - Product Code JAA
  • Reason
    Possible overexposure: failure to apply the entrance exposure rate (eer) tube current limit calibration to the automatic exposure rate (aer) control system when the anatomical profile mode is changed from the default selection to another selection. manual technique modes are not affected.
  • Action
    GE OEC sent a letter to customers December 15, 2007, and scheduled field representative visits for corrective software solution installation.

Device

Device Recall OEC 9900
  • Model / Serial
    All codes
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Finland, Netherlands, Germany, Switzerland, France, United Kingdom, Australia, Italy, Ireland, Spain, Sweden, Belgium, New Zealand, China, Singapore, Poland, Norway, and India.
  • Product Description
    GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
  • Manufacturer
    OEC Medical Systems, Inc

Manufacturer

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