Events

Recall of OEC 9900 Elite

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
    47774
  • Event Risk Class
    Class 2
  • Event Number
    Z-1706-2008
  • Event Initiated Date
    2008-04-15
  • Event Date Posted
    2008-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70151
  • 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
    Image Intensified fluoroscopic x-ray system - Product Code JAA
  • Reason
    Use of existing four-pedal footswitch on a different machine may cause various operational errors.
  • Action
    Consignees were notified by letter on 03/21/2007 and advised that GE would be replacing the 4-pedal switches at some time in the future. Replacement began on 04/15/2008. Contact GE Healthcare at 1-800-874-7378 for assistance.

Device

OEC 9900 Elite
  • Model / Serial
    Serial numbers: E2-0034, E2-0088, E2-0109, E2-0258, E2-0270, E2-7019-MH, E2-7020-MH, E2-7034-CMH, E2-7037-MH, E2-7043-MH, E9-0029, E9-0047, E9-0169, E9-0171, E9-0172, E9-0173, E9-0177, ES-0113, ES-7015-MH.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including one VA facility in FL. No military or foreign distribution.
  • Product Description
    OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
  • 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