Events

Recall of Device Recall EOS System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Eos Imaging 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
    62621
  • Event Risk Class
    Class 2
  • Event Number
    Z-2072-2012
  • Event Initiated Date
    2012-06-19
  • Event Date Posted
    2012-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111193
  • 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
    Solid state x-ray imager ( flat panel/digital imager) - Product Code MQB
  • Reason
    It was discovered of several generator failures of the eos system due to failure of its anode controller board that drives the rotation of the x-ray tube anode.
  • Action
    EOS Imaging notified users by letter on 6/19/12 and that an on site correction would be performed by an EOS Imaging Field Service engineer. EOS indicated in its notification that although this specific defect has not been observed in EOS systems installed in the U.S, they will replace the anode driver boards with new boards equipped with high current capacitors. Similarly, the generator firmware will be upgraded with the software patch that improves the cooling fans' controls. This will be replaced at no charge to the customers, during regularly scheduled preventative maintenance of the user's EOS system. This should be completed by the end of calendar year 2012. Your proposed CAP appears to adequately address the issues you raised in your notification, and is hereby approved. Your proposed customer notification letter as revised, appears to adequately provide instructions with respect to the use of the product pending the correction of the defect and it appears to provide a clear evaluation in nontechnical terms of the potential hazards related to the defect. Your proposed notification letter is hereby approved for distribution to all affected parties. Further questions please call 678-564-5400.

Device

Device Recall EOS System
  • Model / Serial
    All associated Serial Numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution
  • Product Description
    EOS X-ray Medical Diagnostic , X-ray Equipment System || Digital Radiography used in general radiographic examination.
  • Manufacturer
    Eos Imaging Inc

Manufacturer

Eos Imaging Inc
  • Manufacturer Address
    Eos Imaging Inc, 185 Alewife Brook Pkwy Ste 410, Cambridge MA 02138-1104
  • Manufacturer Parent Company (2017)
    EOS Imaging SA
  • Source
    USFDA