Events

Recall of Device Recall GE OEC Brivo 865 plus Laser Aimer

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
    71298
  • Event Risk Class
    Class 2
  • Event Number
    Z-1638-2015
  • Event Initiated Date
    2014-05-22
  • Event Date Posted
    2015-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137256
  • 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
    Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
  • Reason
    Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the us regulations for laser products.
  • Action
    GE Healthcare Surgery Planned Action(s) to repair the defect or to bring the product into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 9 units consisted of the following: 1. Replacing the tube side cover with the laser aimer assembly with a tube side cover without a laser aimer assembly. This correction brought the systems into compliance with applicable US regulations. For further questions please call (801) 536-4615.

Device

Device Recall GE OEC Brivo 865 plus Laser Aimer
  • Model / Serial
    OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of: MD, NC, MT, NJ, UT and NY
  • Product Description
    GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 N Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA