Events

Recall of Millenium VG with Hawkeye/Discovery VH with Hawkeye

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

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
    53883
  • Event Risk Class
    Class 2
  • Event Number
    Z-0496-2010
  • Event Initiated Date
    2009-08-01
  • Event Date Posted
    2010-01-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86803
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • Reason
    Failure to provide the complete user manual information.
  • Action
    A Field Modification Instruction will be released in February 2010. GE Healthcare will correct the Operator Manuals in forward production and the installed base units.

Device

Millenium VG with Hawkeye/Discovery VH with Hawkeye
  • Model / Serial
    All serial numbers associated with model number BR321000008.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Millenium VG with Hawkeye/Discovery VH with Hawkeye, model number: BR321000008. GE Healthcare, Waukesha, Wisconsin 53118. || Generating head and whole body CT images of human subjects.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA