Events

Recall of GE LOGIQ Book

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
    33266
  • Event Risk Class
    Class 2
  • Event Number
    Z-0387-06
  • Event Initiated Date
    2004-09-02
  • Event Date Posted
    2006-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41574
  • 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, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
  • Reason
    The estimated fetal weight (efw) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an efw measurement procedure on the next patient.
  • Action
    Devices will have software upgrades done by GE Field Service Technicians. The upgrade will include a dialog box which will display on the screen when prior data exists and a new patient is being registered.

Device

GE LOGIQ Book
  • Model / Serial
    all serial numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    nationwide and worldwide
  • Product Description
    LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
  • 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