Events

Recall of Device Recall GE LightSpeed Computed Tomography

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
    37007
  • Event Risk Class
    Class 2
  • Event Number
    Z-0804-2007
  • Event Initiated Date
    2006-12-21
  • Event Date Posted
    2007-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50033
  • 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
    CT Scanner - Product Code JAK
  • Reason
    Oil may leak onto the port window of the ct tube and may result in image artifacts that could lead to misdiagnosis.
  • Action
    A Field Modification Instruction was issued to the field to inspect all systems and replace the tube window screws and the window filter, as well as clean any traces of oil in the tube window area. A 12/21/2006, Urgent Product Correction Notice/Customer letter has also been distributed informing the customers of the safety issue and the product correction.

Device

Device Recall GE LightSpeed Computed Tomography
  • Model / Serial
    All serial numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA in the following states and locations: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, Guam and Puerto Rico. Foreign countries include ; Albania, Algeria, Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Canada, Chile, China, Columbia, Czechoslovakia, Denmark, Finland, France, Germany, Great Britain, Greece, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, and Vietnam
  • Product Description
    GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems.
  • Manufacturer
    GE Healthcare

Manufacturer

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