Events

Retiro De Equipo (Recall) de Device Recall Stryker Epic II Critical Care Bed

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 Stryker Medical Div. of Stryker Corporation.

¿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
    56507
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2586-2010
  • Fecha de inicio del evento
    2010-05-14
  • Fecha de publicación del evento
    2010-09-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93824
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Causa
    The fowler mechanism may malfunction, preventing it from being lowered into a flat position.
  • Acción
    Stryker Medical sent an Urgent Medical Device Alert letter dated May 14, 2010 to their customers. The letter identified the product, the problem, and the actions customers should take. The letter instructed users to do the following: " Return the postcard included with the letter to confirm receipt of the notification. " Locate the recalled beds, verify the Fowler mechanism is functioning properly and does not display uneven motion when raising and lowering, and is not unusually noisy. " If the Fowler mechanism is not operating correctly, they were to call Stryker at 1-800-STRYKER, option 1, Reference RA-2010-014 to obtain service for the bed. " If any beds have been loaned or sold, the customer is to forward a copy of the notice to the new users and advise the firm of the new location. " Provide the firm with the serial numbers for any beds that were disposed of. " Retain the revised maintenance manual included with the notification. If the customer had any urgent questions or concerns, they were instructed to call the firm at 800-STRYKER, option 1, reference RA-2010-014, Monday-Friday 8am to 5pm (EST).

Device

Device Recall Stryker Epic II Critical Care Bed
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (all states), and including the countries of ARGENTINA, BRAZIL, CHILE, CHINA, CANADA, MEXICO, GREECE, JAPAN, KOREA, PUERTO RICO, SPAIN, POLAND, TAIWAN, SINGAPORE, INDIA, SWITZERLAND, UK and MALAYSIA.
  • Descripción del producto
    Stryker Epic II Critical Care Bed, Model 2030/2031, Stryker Medical, Kalamazoo, MI. || Critical Care Patient Bed.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Dirección del fabricante
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA