Events

Retiro De Equipo (Recall) de Ceiling Unit CU5001/3 and CU 3-21/23

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-01286-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-13
  • 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-01286-1
  • 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
    The microscope arm of specific ceiling units can be electrically driven from the parked position into the operating field by an electromotive lifting column. the manufacturer moller-wedel has identified that abrasive wear of the drive assembly can occur which could cause a slide-through of the telescopic column into the lowest stop.The microscope arm can be moved upwards and downwards with a levitation height of 40cm by a motorised adjusted telescopic column. if severe abrasive wear occurs the lifting column can slide downwards during lifting procedures up to 40cm onto the lowest stop.
  • Acción
    Device Technologies is advising users to move the telescope column to the lowest position for use without restrictions. Users should attach provided labels to the ceiling unit to indicate that the lifting column is in the lowest position until service has been performed.

Device

Ceiling Unit CU5001/3 and CU 3-21/23
  • Modelo / Serial
    Ceiling Unit CU5001/3 and CU 3-21/23Product Code: CU 5001Reference Number: 604 105Serial Numbers: from P51 up to 274Product Code: CU 5003Reference Number: 604 106Serial Numbers: from P51 up to 127Product Code: CU 3-21Reference Number: 604 650Serial Numbers: from P51 up to P58Product Code: CU 3-23Reference Number: 604 700Serial Numbers: from P51 up to P60ARTG Number: 267878
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd