Events

Recall of GE Healthcare Brivo XR385 DRF/ XRay System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, 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
    64226
  • Event Risk Class
    Class 2
  • Event Number
    Z-0761-2013
  • Event Initiated Date
    2012-08-03
  • Event Date Posted
    2013-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115627
  • 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
    X-ray controls - radiographic - Product Code JAC
  • Reason
    Ge healthcare has become aware of a software issue on the interface of the brivo xr385 dr-f/ model 5271997 radiographic product related to visual indication as mandated by the us code of federal regulations (21cfr) and iec 60601-1-3.
  • Action
    GE Healthcare will, without charge, remedy the issue or bring the product into compliance with each applicable Federal and IEC standard in accordance with a planto be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the software on the system to address the issue. Contact Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification

Device

GE Healthcare Brivo XR385 DRF/ XRay System
  • Model / Serial
    Model Number : 5271997
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
  • Product Description
    GE Healthcare Brivo XR385 DR-F/ X-Ray System || X-Ray System
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA