Events

Recall of Device Recall OEC FlexiView 8800

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
    76568
  • Event Risk Class
    Class 2
  • Event Number
    Z-1469-2017
  • Event Initiated Date
    2017-02-21
  • Event Date Posted
    2017-02-27
  • 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=153546
  • 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
    Oec flexiview 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
  • Action
    On February 21, 2017, an Urgent Medical Device Correction letter was sent to one consignee with an affected unit; a field service representative hand delivered the customer communication.

Device

Device Recall OEC FlexiView 8800
  • Model / Serial
    OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    One consignee in CA.
  • Product Description
    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
  • 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