Events

Retiro De Equipo (Recall) de Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis EDS Light Suspensions

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia Pty 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-00455-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-19
  • 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-00455-1
  • 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
    Stryker has become aware that there is a remote likelihood that the eds light suspension, central axis may have an insufficiently assembled joint in the suspension. if the eds light suspension, central axis falls, it could potentially cause serious injuries to health care providers and/or patients. to date, there have been no adverse events reported to stryker for this issue worldwide.
  • Acción
    A Stryker Technician will contact users to organise a time to perform an inspection of the product. If a correction is required the central axis will be replaced. In the interim, if the product malfunctions, users are to immediately discontinue its use and contact Stryker immediately.

Device

Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis EDS Light Suspensions
  • Modelo / Serial
    Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis EDS Light Suspensions Item Numbers (Serial Numbers):0682-001-566 (15K002818, 15K002498, 15K002518, 15K002508) 0682-400-142 (15L004128)0682-400-148I (16C001798)0682-001-567I (15L006528)ARTG Number: 118878
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA