Events

Recall of Device Recall GE Healthcare Innova 3100 / 3100 IQ

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
    51159
  • Event Risk Class
    Class 2
  • Event Number
    Z-1092-2009
  • Event Initiated Date
    2008-03-06
  • Event Date Posted
    2009-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78873
  • 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 - Product Code MQB
  • Reason
    Ge healthcare reported an issue with the exposure switch redundancy system with innova systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.
  • Action
    On site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units.

Device

Device Recall GE Healthcare Innova 3100 / 3100 IQ
  • Model / Serial
    82416120006, 4103323100, 82416120005, and 214324INNOVA2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including states of MD, TX, and VA and country of China.
  • Product Description
    GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) || Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications.
  • 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