Events

Recall of Device Recall EOS System X ray beam

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
    66833
  • Event Risk Class
    Class 2
  • Event Number
    Z-0529-2014
  • Event Initiated Date
    2013-11-07
  • Event Date Posted
    2014-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123687
  • 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
    Eos imaging discovered during production internal testing that the x-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the x-ray beam operated by the eos system during the x-ray acquisition.
  • Action
    CDRH approves the following conditions for EOS Imaging SA: 1. 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 notes below what are to be included in the notification. The draft letter provided on November 28, 2013, is deficient for the following reasons: a. It does not provide a statement that all repairs will be made without charge (21 CFR 1003.21(3)). b. It does not provide instructions, with respect to the use of the product pending the correction of the defect (21 CFR 1003.21(1). Specifically, the letter should include directions for the user to determine if the collimation defect is currently present in their system, which would initiate immediate correction, rather than at the next semi-annual service. 2. The customer notification letter will be sent in the manner required by 21 CFR 1003.21(b). 3. The repairs outlined are to be completed by July 1, 2014. All systems under service contracts (which includes semi-annual service) would be visited between receipt of this letter and July 1, 2014. All repairs, including those to systems which are not under service contracts, are also expected to be completed by July 1, 2014. EOS may proceed with implementation of the CAP (subject to the conditions noted above. The customer notification letter may be sent out immediately upon addressing the above deficiencies. However, it is suggested that you provide a copy of the revised letter to FDA for approval prior to issuance. For further questions please call (678) 564-5400.

Device

Device Recall EOS System X ray beam
  • Model / Serial
    EOS System
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    EOS System X- ray beam || Digital radiography system used in general radiographic examinations.
  • 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