Events

Recall of Device Recall EOS Imaging

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by EOS Imaging.

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
    66980
  • Event Risk Class
    Class 2
  • Event Number
    Z-0580-2014
  • Event Initiated Date
    2013-11-29
  • Event Date Posted
    2013-12-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124401
  • 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
    System, image processing, radiological - Product Code LLZ
  • Reason
    Error copying information to the clinical file and to the report when two 3d models are opened simultaneously on the stereos workstation.
  • Action
    EOS imaging issued a safety information letter dated November 29, 2013, to the US customer sites. The letter identifed the affected product, problem and actions to be taken. Users of the sterEOS workstation are asked not to simultaneously open several pairs of images in sterEOS 3D. The letter informed customers that EOS imaging will, at it's own expense, corect all systems affected by means of a software update. An EOS imaging representative will contact affected customers to make an appointment for this update once it is available. Users of the sterEOS workstation are asked not to simultaneously open several pairs of images in sterEOS 3D. For questions call +33 (0) 155 25 6060.

Device

Device Recall EOS Imaging
  • Model / Serial
    Software versions: 1.3, 1.4 and 1.5
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images || Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
  • Manufacturer
    EOS Imaging

Manufacturer

EOS Imaging
  • Manufacturer Address
    EOS Imaging, 10 rue Mercoeur 4 Ieme Etage, Paris France France
  • Manufacturer Parent Company (2017)
    EOS Imaging SA
  • Source
    USFDA