Events

Retiro De Equipo (Recall) de SureSigns VSi, VS2+SureSigns VSi - NBP

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia Ltd.

¿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
    RC-2017-RN-01263-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-10-09
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01263-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Philips has identified that certain suresigns vsi, vs2+ products have the date of manufacture on its serial number label as “%dom”, instead of the specific date in the format of yyyy-mm.
  • Acción
    1. Philips will provide affected customers with a new label with "Date of Manufacture" for each unit. An instruction will be provided to impacted customers on how to do the correction. 2. Philips Healthcare will contact customers impacted to arrange for the correction.

Device

SureSigns VSi, VS2+SureSigns VSi - NBP
  • Modelo / Serial
    SureSigns VSi, VS2+SureSigns VSi - NBPProduct Number: 863275SureSigns VSi - NBP/SPO2Product Number: 863276 SureSigns VSi - NBP/SPO2/Temp/WirelessProduct Number: 863277SureSigns VS2+ NBP/SPO2Product Number: 863278SureSigns VS2+ NBP/SPO2/WirelessProduct Number: 863279Multiple Serial NumbersARTG Number: 93971
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA