Events

Recall of Device Recall OEC 8800

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
    37498
  • Event Risk Class
    Class 2
  • Event Number
    Z-0678-2007
  • Event Initiated Date
    2007-03-01
  • Event Date Posted
    2007-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50645
  • 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
    During routine service, primary and/or secondary collimators may not have been properly reinstalled.
  • Action
    Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.

Device

Device Recall OEC 8800
  • Model / Serial
    Serial Numbers: FIB-0020, FIB-0025, FIB-0038, FIB-0050, FIB-0065, 2799PU5, 2832PU4, 3380PU3, 3589PU9, 4037PU8, 4816PU5, 4842PU1, 4860PU3, 5190PU4, 5204PU3, 5210PU0, 5270PU6.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Germany.
  • Product Description
    OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
  • 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