Events

Recall of Device Recall INSIGHT Dental Film

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
    68647
  • Event Risk Class
    Class 3
  • Event Number
    Z-2142-2014
  • Event Initiated Date
    2014-07-02
  • Event Date Posted
    2014-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128396
  • 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
    Film, radiographic - Product Code IWZ
  • Reason
    The indicator dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. this may cause confusion for the dental practitioner. if the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.
  • Action
    Recall notices were mailed to US Customers via overnight carrier on 07/02/2014. Customers are asked to complete an inventory of goods to be returned which will be ultimately destroyed by recalling company. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-933-8031.

Device

Device Recall INSIGHT Dental Film
  • Model / Serial
    Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
  • 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