Events

Retiro De Equipo (Recall) de Accessory Head Rest for Alphastar Operating Tables

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 MAQUET 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
    49545
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0161-2009
  • Fecha de publicación del evento
    2008-10-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-04-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73774
  • 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
    Ac-Powered Operating-Room Table - Product Code FQO
  • Causa
    During installation or cleaning there is a risk of crushing the finger by handling the head rest in the area of the gas strut while simultaneously actuating the release lever.
  • Acción
    Urgent Device Correction letters were sent beginning September 26, 2008 via Fed Ex. Letters identified the potential for finger crush in conjunction with the head rest. Proper operating instructions are provided as well as a warning sticker to be applied to the head rest indicating proper positioning. All letters included a customer response form to be completed by each institution. Information requested is: that device correction letter has been read and instructions followed; that the corrected operating instructions have been received; that the warning sticker has been properly placed on the headrest, or that they do not have the head rest identified in the device correction letter. Questions should be addressed to USA Maquet Inc at 1-888-627-8383 #1.

Device

Accessory Head Rest for Alphastar Operating Tables
  • Modelo / Serial
    USA Part Number 1130.67F0, No serial numbers
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Accessory Head Rest for Alphastar Operating Tables
  • Manufacturer
    MAQUET Inc.

Manufacturer

MAQUET Inc.
  • Dirección del fabricante
    MAQUET Inc., 1140 Us Highway 22 Ste 202, Bridgewater NJ 08807-2958
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA