Events

Recall of Device Recall Kodak Direct View DR3000 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
    38248
  • Event Risk Class
    Class 2
  • Event Number
    Z-0717-2007
  • Event Initiated Date
    2007-03-06
  • Event Date Posted
    2007-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53238
  • 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
    X Ray System - Product Code KPR
  • Reason
    The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. this results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21code of federal regulations (cfr).
  • Action
    On 3/06/07, Eastman Kodak notified CDRH of its proposed Corrective Action Plan (CAP). The CAP was approved by CDRH under the following conditions: (1) Kodak will visit each user facility, and apply dial indicator labels to the collimator knobs, apply a field size label to the collimator housing, and verify that each system complies with the field indication performance standard. (2) Kodak will prepare adequate instructions for the assembly/installation and testing of the dial indicators labels and field size labels. These instructions are to be furnished to all owners of the Kodak Direct View DR3000 Systems. (3) Kodak will supplement the Kodak DR3000 system product report with a copy of the adequate instructions. (4) Kodak will perform 100% verification of the recall effectiveness. (5) Kodak will not charge for the corrections and will reimburse the owner for any out-of-pocket expenses. (6) Kodak will notify the manufacturer of the Ralco 302 ACS collimators, Ralco, that the collimator is noncompliant with the performance standard.

Device

Device Recall Kodak Direct View DR3000 System
  • Model / Serial
    Serial Numbers DR30001001, DR30001004, DR30001006, DR30001014, DR30001016, DR30001017, DR30001020, DR30001021, DR30000032.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL, NY, MO, MI, TX, and Canada
  • Product Description
    Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

Carestream Health, Inc.
  • Manufacturer Address
    Carestream Health, Inc., 1049 West Ridge Road, Rochester NY 14615
  • Source
    USFDA