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
    70732
  • Event Risk Class
    Class 2
  • Event Number
    Z-1460-2015
  • Event Initiated Date
    2015-02-17
  • Event Date Posted
    2015-05-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134571
  • 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
    When performing calibration, an alert message on the spectral filtration of the x-ray beam may be suppressed. improper filtration of the x-ray beam can then occur in exams set up with copper filtration.
  • Action
    Planned Action of EOS Imaging Inc.: 1. Install a new acquisition software version, which will prevent use of the system when improper filter positioning is detected. 2. A customer notification letter which includes a statement that EOS Imaging will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following CDRH approves the CAP subject to the following conditions: 1. Provide documentation to show that all filter positioning subassemblies have been replaced, which you state was implemented to prevent improper filter positioning. 2. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 3. EOS Imaging will implement this CAP by September 1, 2015. For further questions call (678) 564-5400.

Device

Device Recall EOS system
  • Model / Serial
    Model Number - EOS System
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
  • Product Description
    EOS, Digital radiography system used in general radiographic examinations.
  • 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