Events

Recall of Device Recall Xray system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE OEC Medical Systems,Inc.

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
    26383
  • Event Risk Class
    Class 2
  • Event Number
    Z-0947-03
  • Event Initiated Date
    2003-05-12
  • Event Date Posted
    2003-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27594
  • 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, Fluoroscopic, Image-Intensified - Product Code JAA
  • Reason
    Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
  • Action
    A Product Safety Alert letter was sent to all consignees on 5/12/2003 recommending that all hand controls be removed from the units.

Device

Device Recall Xray system
  • Model / Serial
    Serial numbers beginning with W2 and W9.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland.
  • Product Description
    Uroview 2600 Uroview System
  • Manufacturer
    GE OEC Medical Systems,Inc

Manufacturer

GE OEC Medical Systems,Inc
  • Manufacturer Address
    GE OEC Medical Systems,Inc, 384 Wright Brothers Drive, Salt Lake City UT 84116
  • Source
    USFDA