Events

Retiro De Equipo (Recall) de MAVIG PORTEGRA 2 system

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 Siemens Medical Solutions USA, 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
    63496
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0515-2013
  • Fecha de inicio del evento
    2012-10-10
  • Fecha de publicación del evento
    2012-12-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114053
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • Causa
    A particular component may not have been fitted during the installation of some mavig portegra 2 systems.
  • Acción
    Siemens sent a Customer Safety Advisory Notice on October 3, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were reminded that they should contact the service department in the event of damage or other irregularity. Customers were instructed to forward the information contained in the notice to their employees responsible for the operation of the affected product. Customers were also asked to forward the safety information to other organization affected by the product and to any users of the product. For questions regarding this recall call 610-219-4834.

Device

MAVIG PORTEGRA 2 system
  • Modelo / Serial
    Part numbers 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281183
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system || Ceiling mounted surgical light
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA