Events

Recall of Device Recall GE Advantx

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Med Systems.

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
    28747
  • Event Risk Class
    Class 2
  • Event Number
    Z-0896-04
  • Event Initiated Date
    2004-03-24
  • Event Date Posted
    2004-07-20
  • 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=32451
  • 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, X-Ray, Angiographic - Product Code IZI
  • Reason
    Unintended movements of both the c-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
  • Action
    Field modification instructions were issued on 3/24/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to the hospitals.

Device

Device Recall GE Advantx
  • Model / Serial
    All serial numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were distributed nationwide in the United States and worldwide.
  • Product Description
    Advantx 1 SC Model 36006617 Angiographic X-ray System
  • Manufacturer
    General Electric Med Systems

Manufacturer

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