Events

Recall of Device Recall KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500

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
    67188
  • Event Risk Class
    Class 2
  • Event Number
    Z-0844-2014
  • Event Initiated Date
    2013-12-26
  • Event Date Posted
    2014-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124908
  • 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
    Carestream health, inc. has recalled dr 7500 dual detector system utilizing version 5.X software due to a possible patient image display error.
  • Action
    On December 26, 2013 Carestream Health, Inc. distributed Urgent Medical Device Recall notification letters dated December 19, 2013 to their customers via Fed Ex. Carestream Health, Inc. recommends that once the daily detector calibration process is initiated on the DR 7500 System running Version 5.X software it should not be interrupted. The calibration process should be completed only when patients are not being imaged. A Carestream Health Service representative will contact all customers to install a software modiciation to Version 5.X software which will not allow the cancellation of detector calibration. Customers will questions can call 1-800-328-2910 7 days per week on a 24 hour basis.

Device

Device Recall KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500
  • Model / Serial
    Service Code: 8087; Catalog numbers: 8791345, 1155118, 1295088, 8551046, 8791345, 1666700, 8531675
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    worldwide Distribution - US (Nationwide) including states of: IN, PA, MD, MI, NY, GA, MN, OK, VA, TX, WI, CA, IL, TN, WA, NC, SC, MA, NJ, and KY; and Internationally to: Canada, New Zealand, South Korea, Australia, Hong Kong, Saudia Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, UK, Sweden, Poland, Denmark, Germany, Finland, Czech Republic, Italy, France, Portugal and Spain.
  • Product Description
    KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

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