Retiro De Equipo (Recall) de Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the patient area)

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    The manufacturer has become aware of a case in which the monitor support bracket has detached from the joint pin at the bottom of the height adjustable ac3000 spring arm and fallen down together with the monitor until it was only held by the electrical cable connections. an inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin. investigation showed that the support shoulder of the locking element in the aluminum pin's groove is too low in an unfavorable tolerance position. the frequent movement of the arm under load may cause the locking element to damage the pin's groove and ultimately shear off, which may then result in the reported event.
  • Acción
    Stryker Service Technician to inspect and correct Spring Arm Circlips.


  • Modelo / Serial
    Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the patient area)Product numbers: 0682001270, 0682001274, 0682000226 & 06824000591Multiple lot numbers affectedARTG Number: 118878
  • Clasificación del producto
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source