Events

Retiro De Equipo (Recall) de Device Recall GammaMed Plastic Needle with Mandrin

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 Varian Medical Systems, Inc. Oncology Systems.

¿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
    59401
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2991-2011
  • Fecha de inicio del evento
    2011-07-13
  • Fecha de publicación del evento
    2011-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102635
  • 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
    System, applicator, radionuclide, remote-controlled - Product Code JAQ
  • Causa
    Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal.
  • Acción
    Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated July 13, 2011 to all possibly affected customers. This notification supplements and modifies the previous "Customer Technical Bulletins" originally sent in September 2008. The initial Customer Technical Bulletins informed customers of the possibility that needle tips cans crack and separate. It also reminded users that the product has a limited life and to check needles prior to use as per instructions. Current correction notice letter instruct customers to stop using any plastic needles in inventory with lot numbers C01 to D01 and those with lot numbers starting with H or I. The letter also request that the recalled products be returned to Varian BrachyTherapy for replacement. The letters include information as to where the lot number is located on the device. All appropriate personnel should be notified of the correction notice. Contact information is provided for all geographical areas. USA contact for questions or concerns is 1-800-360-7909.

Device

Device Recall GammaMed Plastic Needle with Mandrin
  • Modelo / Serial
    Part numbers GM11007560;  All lots C01 to D01 and lots H and I
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Austria, Bangladesh, Belgium, Brazil, Canada, Columbia, Cyprus, Czech Republic Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, India, Japan, Kazahastan, Kuwait, Lebanon, Macedonia, Mexico, Moldova, Nepal New Zealand, Norway, Pakistan, Philippines, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Arab Emirates Uruguay, United Kingdom, and Venezuela.
  • Descripción del producto
    GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. || Remote controlled radionuclide applicator system. || Varian Medical Systems, Inc. || Mfg by Varian Medical Systems Haan GmbH, Haan, Germany || Product Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Dirección del fabricante
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Empresa matriz del fabricante (2017)
    Varian Medical Systems Inc
  • Source
    USFDA