Events

Recall of Device Recall Imageintensified fluoroscopic 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
    37191
  • Event Risk Class
    Class 2
  • Event Number
    Z-0515-2007
  • Event Initiated Date
    2007-01-15
  • Event Date Posted
    2007-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50129
  • 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
    fluoroscopic x-ray system - Product Code JAA
  • Reason
    Uroview 2800 system with 3 phase power distribution box (wonder box) option can present a shock hazard to the user if the access door to the power box is not completely closed when the unit is powered on. .
  • Action
    Consignees were notified by letter on 01/15/2007. Instructions were given to position and not move the dual monitors until inspection and correction by GE personnel. For the affected units with a 3 phase power distribution box, users were cautioned to ensure that the access door to the power box is completely closed when the unit is powered on to prevent a shock hazard.

Device

Device Recall Imageintensified fluoroscopic xray system.
  • Model / Serial
    Model Numbers 882082-01, 882082-02, 886765-01. Units with manufactured dates between 03/2003 and 08/2006.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Africa, Switzerland, and Venezuela.
  • Product Description
    OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA