Events

Recall of STEREOS WORKSTATION SYSTEM LOGICIEL EOS 3D RECONSTRUCTION

According to Health Canada (via FOI), this recall involved a device in Canada 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
    60301
  • Event Risk Class
    II
  • Event Initiated Date
    2014-05-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Oes imaging has discovered during internal testing that images or graphics included in the patient clinical files and reports could be wrong when two image series are opened and reviewed simultaneously with the 3d module of the stereos workstation.

Device

STEREOS WORKSTATION SYSTEM LOGICIEL EOS 3D RECONSTRUCTION
  • Model / Serial
    Model Catalog: EOS 3D RECONSTRUCTION (Lot serial: Version 1.4); Model Catalog: EOS 3D RECONSTRUCTION (Lot serial: Version 1.5)
  • Product Description
    STEREOS WORKSTATION SYSTEM LOGICIEL EOS 3D RECONS
  • Manufacturer
    EOS IMAGING

Manufacturer

EOS IMAGING
  • Manufacturer Address
    PARIS
  • Manufacturer Parent Company (2017)
    EOS Imaging SA
  • Source
    HC