Events

Recall of Device Recall Model Kodak 2100 Intraoral XRay 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
    67349
  • Event Risk Class
    Class 2
  • Event Number
    Z-1127-2014
  • Event Initiated Date
    2014-01-24
  • Event Date Posted
    2014-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125303
  • 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
    Unit, x-ray, extraoral with timer - Product Code EHD
  • Reason
    Carestream received problem reports relating to apparent early failure of kodak 2x00 intraoral x-ray device arms leading to arm breakage.
  • Action
    Urgent Medical Device Recall Letters (dated 1/24/2014) were sent to the consignees on 1/24/2014 via Certified Mail, Return Receipt Requested.

Device

Device Recall Model Kodak 2100 Intraoral XRay System
  • Model / Serial
    Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. USA (nationwide) and the country of Canada.
  • Product Description
    Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.
  • Manufacturer
    Carestream Health Inc.

Manufacturer

Carestream Health Inc.
  • Manufacturer Address
    Carestream Health Inc., 150 Verona St, Rochester NY 14608-1733
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    USFDA