Events

Recall of KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems

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
    31494
  • Event Risk Class
    Class 2
  • Event Number
    Z-0817-05
  • Event Initiated Date
    2005-04-08
  • Event Date Posted
    2005-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37987
  • 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
    Grid, Radiographic - Product Code IXJ
  • Reason
    Screens may be affected with image artifacts.
  • Action
    Letters mailed 4/8/2005. Customers informed of the problem and advised that Kodak representatives will exchange the recalled screens for new screens.

Device

KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems
  • Model / Serial
    Each screen has a 17-digit code. Product subject to recall includes ALL codes containing ''CE'' and ''CR'' and codes with ''CO'' with date code of ''051'' or lower. NOTE: The date codes are the 8th thru 10th digit and equal the julian date. The YEAR CODES are the 11th and 12th digit. The codes are located at the top edge of the CR screen. i.e. xxxxxxx051CO#xxxx.
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    There are 263 U.S. customers; 22 Canadian customers; 74 Japanese customers; 213 Greater Asian Region customers; 19 Latin American customers; 306 Europe/Africa/ Middle East customers.
  • Product Description
    KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label: Made in U.S.A. by Eastman Kodak Company, Rochester, N.Y. 14650. Screens are sold in the following sizes and Cat. Nos: || (1) Cat. #812-7334 - 15 x 30 cm; || (2) Cat #825-9269 - 18 x 24 cm; || (3) Cat #167-8663 - 24 x 30 cm; || (4) Cat #810-7823 - 35 x 35 cm; || (5) Cat #160-5906 - 35 x 43 cm
  • Manufacturer
    Eastman Kodak Co

Manufacturer

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