Events

Recall of Device Recall GE Healthcare OEC 9900 Elite

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
    76074
  • Event Risk Class
    Class 2
  • Event Number
    Z-1060-2017
  • Event Initiated Date
    2016-12-27
  • Event Date Posted
    2017-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152099
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    Ge healthcare surgery announces a voluntary field action for the oec 9800 and oec 9900 elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
  • Action
    The customer communication is expected to begin distribution in January 2017. Consignees will be notified of the availability of the Operator Manual supplement via a letter. No product is being returned.

Device

Device Recall GE Healthcare OEC 9900 Elite
  • Model / Serial
    Manufactured from Oct 2005 to present
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including govt/VA/military and foreign consignees.
  • Product Description
    OEC 9900 Elite. MDL Numbers: D148942, D155043
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 N Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA