Events

Retiro De Equipo (Recall) de Device Recall Stryker Medical S3 MedSurg 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 Division 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
    73255
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2353-2016
  • Fecha de inicio del evento
    2016-02-02
  • Fecha de publicación del evento
    2016-08-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143629
  • 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
    Cpu board failures cause fowler (backrest) electronic controls to stop working.
  • Acción
    Stryker Medical initiated a voluntary recall of the S3 MedSurg Bed, Model 3005, with notices sent on February 2, 2016 via certified mail. Stryker medical identified that Fowler does not raise up to desired angle; and the Fowler does not raise electronically, but manual function remains operational through the manual CPR release. Actions Needed for Customers: 1. Locate the bed(s) listed by serial number on the attached business reply form. 2. A Stryker ProCare Representative will contact your facility to schedule a time for repair. 3. Fax (269)488-8691 or email productfieldaction@stryker.com the enclosed business reply form to confirm receipt of this notification. 4. If you have further distributed the beds listed in this letter, please forward a copy of this notice to the new users and advise us of their new location. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Normal business hours are Monday-Friday 8 a.m-5 p.m. (ET).

Device

Device Recall Stryker Medical S3 MedSurg Bed

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Dirección del fabricante
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA