Events

Recall of GE CT system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Med 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
    30278
  • Event Risk Class
    Class 2
  • Event Number
    Z-0269-05
  • Event Initiated Date
    2004-10-21
  • Event Date Posted
    2005-02-24
  • 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=35602
  • 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
    Table, Radiographic, Tilting - Product Code IXR
  • Reason
    The patient tables of the affected ct systems are supported by a hydraulic cylinder and a cylinder shaft (i.E. the upper shaft) which connects the tabletop to the table frame. ge received a report of a hispeed lx/i system table falling abruptly due to the filure of the upper shaft. no injuries were reported.
  • Action
    Inadequate materials used to manufacture the upper shaft of patient tables that can result in uncontrolled table motion.

Device

GE CT system
  • Model / Serial
    Model or Catalog: 2297024, 2320315, 2244226, 2113694-2, 2115992-4, 2200290-2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Product Description
    Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.
  • Manufacturer
    General Electric Med Systems LLC

Manufacturer

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