Events

Recall of GE OEC 9900 Elite Fluoroscopic Xray 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
    36400
  • Event Risk Class
    Class 2
  • Event Number
    Z-0041-2007
  • Event Initiated Date
    2006-09-13
  • Event Date Posted
    2006-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48596
  • 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
    Missing, mixed or lost patient images may result after x-ray procedures. error in navigation accuracy.
  • Action
    Consignees will be notified by letter beginning 10/16/2006.

Device

GE OEC 9900 Elite Fluoroscopic Xray system.
  • Model / Serial
    Catalog Numbers 887208 and 887210. Serial numbers E9-0002-G, E9-0004-G, E9-0014-G, E9-0032-G, E9-0035-G, E9-0036-G, E9-0040-G, E9-0041-G, E9-0042-G, ES-0002-G, ES-0003-G, ES-0013-G, ES-0014-G, ES-0015-G, ES-0016-G, ES-0018-G, ES-0020-G, ES-0021-G, ES-0023-G, ES-0024-G, ES-0025-G, ES-0026-G, ES-0027-G, ES-0028-G, ES-0031-G, ES-0032-G, ES-0033-G, ES-0034-G, ES-0035-G, ES-0040-G, ES-0041-G, ES-0042-G, ES-0043-G, ES-0044-G, ES-0081-G, ES-0082-G, ES-0083-G, ES-0084-G, ES-0085-G, ES-0086-G.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL, GA, IL, IN, LA, MA, MD, MO, NH, NJ, PA, TX, UT. Includes one VA facility in PA. China, France.
  • Product Description
    GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.
  • 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