Events

Recall of Millennium VG, Discovery VH, Varicam

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Med 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
    29988
  • Event Risk Class
    Class 2
  • Event Number
    Z-0012-05
  • Event Initiated Date
    2004-09-03
  • Event Date Posted
    2004-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34918
  • 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
    System, Tomography, Computed, Emission - Product Code KPS
  • Reason
    Ge healthcare received reports of intermittent low ejection fraction (ef) results for muga (multi-gated acquisitions) studies on millennium vg systems. this issue can occasionally lead to distortions in the volume curve in some muga studies, and result in calculated ef values lower (never higher) than actual values. a low ef value could lead to a physician decision to stop needed treatment.
  • Action
    A letter dated August 5, 2004 was released to customers describing the issue and recommending that users pay special attention to any volume curve which appears to be abnormal or any EF values that appear to be lower than expected, and not to rely soley on this value for diagnosis purposes until they recieve the SW patch. A SW patch will be distributed shortly to all affected systems.

Device

Millennium VG, Discovery VH, Varicam
  • Model / Serial
    Each unit has a unique serial code. All serial numbers are being recalled.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide throughout the United States and worldwide.
  • Product Description
    Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
  • Manufacturer
    General Electric Med Systems LLC

Manufacturer

General Electric Med Systems LLC
  • Manufacturer Address
    General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA