Events

Retiro De Equipo (Recall) de Device Recall KODAK TMAT L/RA Film

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Carestream Health, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    54981
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1314-2010
  • Fecha de inicio del evento
    2010-03-12
  • Fecha de publicación del evento
    2010-04-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89615
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    film, radiographic - Product Code IWZ
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Lot 533 012
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and Puerto Rico, Australia, Canada, Chile, El Salvador, Honduras, and New Zealand
  • Descripción del producto
    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.
  • Dirección del fabricante
    Carestream Health, Inc., 150 Verona Street, Rochester NY 14608-1733
  • Empresa matriz del fabricante (2017)
    ONEX Corp
  • Source
    USFDA