Events

Recall of OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance

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
    75330
  • Event Risk Class
    Class 2
  • Event Number
    Z-0071-2017
  • Event Date Posted
    2016-10-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150056
  • 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
    Ge healthcare surgery announces a voluntary field action for the oec brivo 715 prime, oec brivo 685 essential, and oec brivo 865 advance because the circuit board that controls vertical motion of the c-arm may fail, resulting in the c-arm moving up or down without command.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter dated September 23, 2016 to customers. The letter informed customers of the affected product, safety issue, and safety instructions for immediate mitigation of the issue. GE Healthcare will correct all affected products at no cost to customers. A GE Healthcare representative will the customers to arrange for the correction. Please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance
  • Model / Serial
    GE Brivo OEC715: Serial Numbers B2S15158 to B2S15164; B2S15166 to B2S15171; B2S15173 to B2S15195; B2S15197; B2S15200; B2S15202; B2S16046; B2S16050; B2S16051  GE Brivo OEC785: Serial Numbers B3S15236; B3S15241; B3S15242; B3S15246; B3S15248; B3S15250; B3S15253 to B3S15257; B3S15259 to B3S15338; B3S15353; B3S15357 to B3S15359; B3S16152  GE Brivo OEC865: Serial Numbers B4S15063 to B4S15070; B4S15072; B4S15073; B4S15075; B4S16029
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees.
  • Product Description
    OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance || Product Usage: || The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections or biopsy. The OEC Brivo is not indicated for interventional use.
  • 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