Events

Recall of Device Recall Innova 3100

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
    34758
  • Event Risk Class
    Class 2
  • Event Number
    Z-0897-06
  • Event Initiated Date
    2006-03-06
  • Event Date Posted
    2006-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45083
  • 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
    Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
  • Reason
    Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.
  • Action
    GEHC is issuing a validated field action 3/6/2006 to correct the issues. Existing screws/bolts will be replaced using correct torque with screws containing cotter pins. Loctite liquid glue will be applied. Service manuals have been updated with instructions for using correct screws and torque. The field action is being implemented via Field Modification Instruction (FMI) 12033.

Device

Device Recall Innova 3100
  • Model / Serial
    all devices manufactured before November 2005
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide including Puerto Rico and OUS to include: Australia, Belgium, Brazil, Bulgaria, Byelarus, Canada, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Indonesia, Iraq, Ireland, Israel, India, Iran, Italy, Jordan, Japan, Republic of Korea, Lebanon, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic of China, Thailand, Tunisia, Turkey, United Kingdom, Venezuela
  • Product Description
    GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option, Cardiovascular Imaging System.
  • 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