Events

Recall of Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Eastman Kodak Co.

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
    28438
  • Event Risk Class
    Class 2
  • Event Number
    Z-0728-04
  • Event Initiated Date
    2004-02-20
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31897
  • 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
    Defective component in overhead tube support balancer may cause the suspended load to fall.
  • Action
    2/20/2004: Field representatives notified the customer in China that the unit should not be used until the OTS Balancer component can be repaired/replaced.

Device

Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system...
  • Model / Serial
    Serial Numbers affected: 4193-5702, 4193-5704, 4193-5705, 4193-5706, 4193-5708
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Amsterdam, China and Kuwait.
  • Product Description
    Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.
  • Manufacturer
    Eastman Kodak Co

Manufacturer

Eastman Kodak Co
  • Manufacturer Address
    Eastman Kodak Co, 343 State St, Rochester NY 14650-1131
  • Source
    USFDA