Events

Retiro De Equipo (Recall) de Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)

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-2014-RN-00361-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-25
  • 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-2014-RN-00361-1
  • 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 possibility that the lock washer and screw that secures the monitor onto the shape arm may not be present. if the shape arm lock washer and screw are not present the monitor could separate and dislodge from the arm potentially resulting in injury.
  • Acción
    Stryker is inspecting all affected Shape Arms to determine if the lock washer and screw are missing. If missing a new lock washer and screw will be fitted.

Device

Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)
  • Modelo / Serial
    Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)Shape Arm Kit LeftCatalogue Number: 0682000976 Serial Numbers: 080924DC001 through 120227DC025Shape Arm Kit RightCatalogue Number: 0682000977 Serial Numbers: 080909DB001 through 131021DB013ARTG Number: 118878
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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