Events

Retiro De Equipo (Recall) de Stryker Medical transport stretcher

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
    52229
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0285-2010
  • Fecha de inicio del evento
    2009-08-10
  • Fecha de publicación del evento
    2009-11-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83188
  • 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
    stretcher - Product Code FPO
  • Causa
    The brake/steer pedal may seize, resulting in the brakes not working.
  • Acción
    Consignees were notified by letter dated August 10, 2009 that Stryker will contact them to upgrade the stretchers within 6 months. The recall was expanded in scope to include additional serial numbers by a second letter dated September 17, 2009, which was issued to additional consignees who had not been previously notified of the recall, as well as the consignees who had been issued the August 10, 2009 letter.

Device

Stryker Medical transport stretcher
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, Japan, Korea, Latin America, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Singapore, South Africa, Spain, Switzerland, Taiwan, and United Kingdom,
  • Descripción del producto
    Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 737 (also known as Model ST104). || Wheeled hospital stretcher.
  • 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