Events

Retiro De Equipo (Recall) de Device Recall Eye Surgery Stryker Medical Stretchers Model 1089

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
    59201
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2864-2011
  • Fecha de inicio del evento
    2011-07-19
  • Fecha de publicación del evento
    2011-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102121
  • 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, Wheeled - Product Code FPO
  • Causa
    The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa.
  • Acción
    Stryker Medical sent an "Urgent Medical Device Correction" dated July 19 ,2011 to all affected customers. The letter included; the name and model numbers of the stretchers, the reason for the correction and dates of manufacture. It contained the instructions to check the braking system and if found to be inoperable, to remove it from service, and if operable to check prior to each use. Also, information regarding contacting the recipients of any loaned or sold stretchers to relay the information in the letter and Medwatch reporting information. A self addressed postcard to confirm receipt of the letter was also included. For additional information call (269) 389-6604.

Device

Device Recall Eye Surgery Stryker Medical Stretchers Model 1089
  • Modelo / Serial
    Model: 1089 Lots: 1102034587, 1102034588, 1102034589, 1102034590, and 1102034591.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: Nationwide (USA) including the states of NY, MI, LA and CA ,and the countries of Canada, China, Spain, Japan, Korea, United Kingdom, South Africa.
  • Descripción del producto
    Eye Surgery Stryker Medical Stretchers Model 1089 || Intended to transport patients in a horizontal position.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

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