Events

Recall of Device Recall KODAK TMAT G/RA 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
    54981
  • Event Risk Class
    Class 3
  • Event Number
    Z-1315-2010
  • Event Initiated Date
    2010-03-12
  • Event Date Posted
    2010-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89616
  • 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
    Product mix-up. the firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be t-mat l/ra, it was performing like t-mat g/ra.
  • Action
    A "MEDICAL DEVICE RECALL (VOLUNTARY)" letters and Response Forms (dated 3/12/10) were sent to the customers on 3/12/10 via Certified Mail, Return Receipt Requested. The foreign sales offices are being notified via e-mail (started on 3/12/10) so that they in turn can notify the foreign consignees of the recall action and report back to Carestream Health. The letter describes the products, problem and action to be taken by the customers. The customers should identify and remove from inventory shelves any product that is listed in the recall, complete and return the attached Product Information Form whether they have affected product or not by fax to Carestream Health Customer Service 1-800-445-9967. Carestream Health will organize the return through designated carriers and will pay for transportation; and supply replacement stock in a timely manner. If you have any questions, concerns, or product technical questions, please call or fax Customer Service or Technical support at 1-800-328-2910.

Device

Device Recall KODAK TMAT G/RA Film
  • Model / Serial
    Lot 835 021
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and Puerto Rico, Australia, Canada, Chile, El Salvador, Honduras, and New Zealand
  • Product Description
    KODAK T-MAT G/RA Film, Catalog/REF # 151 0023, 24x30 cm, 5-100 Sheet Boxes FOLHAS/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904 || Intended use: Imaging film
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

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