Events

Recall of Device Recall LightSpeed VCT 7.2 Vision

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ge Healthcare.

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
    54178
  • Event Risk Class
    Class 2
  • Event Number
    Z-0669-2010
  • Event Initiated Date
    2009-10-01
  • Event Date Posted
    2010-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87769
  • 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 properly document the ctdi in the technical reference or user manual.
  • Action
    GE is sending an Important Electronic Product Radiation Warning letter to customers. The letter will describe the defect, identify the affected product details, provide instructions, state the product correction, and the necessary contact information.

Device

Device Recall LightSpeed VCT 7.2 Vision
  • Model / Serial
    Serial numbers associated with the mentioned Gantry model numbers manufactured from May 2009 to November 2009.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Including states of CT, SD, VA, WA, MA, PA, GA, IL, CA, MD, NY, NC, SC, AZ, TX, MT, FL, OH, OK, MI, CO, ME, WV, TN, KS, and WI.
  • Product Description
    LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 5129909-11 gantry. || For head, whole body, cardiac and vascular X-ray Computed Tomography applications.
  • Manufacturer
    Ge Healthcare

Manufacturer

Ge Healthcare
  • Manufacturer Address
    Ge Healthcare, 9900 W Innovation Dr, Wauwatosa WI 53226-4856
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA