Events

Rappel de Device Recall KODAK TMAT L/RA Film

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Carestream Health, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    54981
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1314-2010
  • Date de mise en oeuvre de l'événement
    2010-03-12
  • Date de publication de l'événement
    2010-04-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-07-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89615
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    film, radiographic - Product Code IWZ
  • Cause
    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 L/RA Film
  • Modèle / numéro de série
    Lot 533 012
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and Puerto Rico, Australia, Canada, Chile, El Salvador, Honduras, and New Zealand
  • Description du dispositif
    KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 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.
  • Adresse du fabricant
    Carestream Health, Inc., 150 Verona Street, Rochester NY 14608-1733
  • Société-mère du fabricant (2017)
    ONEX Corp
  • Source
    USFDA