Events

Recall of EOS

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
    101797
  • Event Risk Class
    II
  • Event Initiated Date
    2015-02-18
  • 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
    An alert message on the spectral filtration of the x-ray beam is possibly not managed appropriatly at the time of its appearance during the daily calibration of the system.

Device

EOS
  • Model / Serial
    Model Catalog: EOS (Lot serial: 3.1009.127); Model Catalog: EOS (Lot serial: 3.1210.220); Model Catalog: EOS (Lot serial: 5.1410.300); Model Catalog: EOS (Lot serial: 3.1306.239); Model Catalog: EOS (Lot serial: 3.1310.255); Model Catalog: EOS (Lot serial: 3.1303.231); Model Catalog: EOS (Lot serial: 5.1409.290)
  • Product Description
    EOS
  • Manufacturer
    EOS IMAGING

Manufacturer

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