Events

Recall of Device Recall GE Medical Systems Revolution

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
    25531
  • Event Risk Class
    Class 2
  • Event Number
    Z-0157-03
  • Event Initiated Date
    2002-11-21
  • Event Date Posted
    2003-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25985
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code 90LMA
  • Reason
    The devices do not meet requirements in 21 cfr 1010.2 in that they lack certification labels.
  • Action
    Field modification instructions were issued on 11/21/02 to GE field engineers who placed the certification label on the equipment.

Device

Device Recall GE Medical Systems Revolution
  • Model / Serial
    All serial numbers in distribution at the time of the recall.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product had been shipped to hospitals located nationwide in the United States.
  • Product Description
    Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems
  • Manufacturer
    General Electric Med Systems

Manufacturer

General Electric Med Systems
  • Manufacturer Address
    General Electric Med Systems, 3000 N Grandview Blvd, Waukesha WI 53186
  • Source
    USFDA