Events

Recall of Device Recall Revolution XR/d

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
    37654
  • Event Risk Class
    Class 2
  • Event Number
    Z-1788-2012
  • Event Initiated Date
    2006-05-31
  • Event Date Posted
    2012-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51229
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a proteus xr/a table while moving the tabletop with the thumb placed over its edge and fingers underneath.
  • Action
    GE Healthcare sent an "URGENT SAFETY INFORMATION" letter dated May 31, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included new operator instructions and warning labels.

Device

Device Recall Revolution XR/d
  • Model / Serial
    all serial numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 || Model numbers: 2259988-2 & 2351505. || The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
  • 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