Events

Recall of Device Recall Kodak DirectView DR 7500 Diagnostic XRay System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carestream Health, 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
    68727
  • Event Risk Class
    Class 2
  • Event Number
    Z-2177-2014
  • Event Initiated Date
    2014-07-09
  • Event Date Posted
    2014-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128573
  • 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
    System, x-ray, stationary - Product Code KPR
  • Reason
    An on-site evaluation of the equipment parts that attach the beta assembly (x-ray tube and collimator) to the over head tube crane (otc) telescope was completed by carestream health (csh) service engineering. inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the beta assembly detached from the otc telescope, the lock nut was not sufficiently tightened.
  • Action
    Carestream will notify all DR 7500 customers of the issue and schedule a Field Engineer to inspect and repair the system if required. Specific instructions (Service Modification) for the inspection and repair will followed by the Carestream Field Engineer in order to complete the correction. Documented evidence of the Field Engineer visit will be noted in the Carestream service engineering record for each affected system. Carestream estimates that the plan of correction will be completed within 2-4 weeks

Device

Device Recall Kodak DirectView DR 7500 Diagnostic XRay System
  • Model / Serial
    The device can be tracked according to service code. The service code for the DR 7500 system is 8087.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of (United Kingdom, United Arab Emirates, Turkey, Taiwan, Switzerland, Sweden, Spain, South Africa, Portugal, Poland, Oman, New Zealand, Netherlands, Kuwait, Italy, Israel, Hong Kong, Germany, France, Finland, Denmark, Dubai, Czech Republic, China, Korea, Belgium, Australia, and Amsterdam.
  • Product Description
    Kodak DirectView DR 7500 Diagnostic X-Ray System || Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

Carestream Health, Inc.
  • Manufacturer Address
    Carestream Health, Inc., 1049 W Ridge Rd, Rochester NY 14615-2731
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    USFDA