Events

Recall of Kodak DirectView DR 71 System

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
    33931
  • Event Risk Class
    Class 2
  • Event Number
    Z-0274-06
  • Event Initiated Date
    2005-10-20
  • Event Date Posted
    2005-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42757
  • 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
    Potential weld defect in the overhead tube support assembly which connects the tube assembly to the telescoping arm. this could cause the tube assembly to fall, injuring anyone near the unit.
  • Action
    Letters dated 10/20/2005 were hand carried by Kodak Field Service Reps. Kodak Field Engineers inspected units and found the two defective units (both in China).

Device

Kodak DirectView DR 71 System
  • Model / Serial
    s/n DR71000121 and DR71000123.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    DOMESTIC: 12 units shipped to 12 medical facilities in FL, KY, MI, NY, OH, PA, and SC. FOREIGN: 12 units shipped to 7 hospitals in China, 1 warehouse in China; 1in the possession of Chinese Customs (government); and 1 is in a warehouse in Russia.
  • Product Description
    KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major 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
  • Source
    USFDA