Events

Retiro De Equipo (Recall) de STERIS 4085, 4085 SS and 4085 Feather Weight Leg Section (FLWS) Surgical tables

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-2014-RN-00884-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-08
  • 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-00884-1
  • 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
    Steris has determined there is a potential that if the surgical table feet become unlocked from the floor during a procedure, the hand control may incorrectly indicate that the table feet are locked and still contacting the floor. the user may not realise that the table is unlocked and is able to continue articulating the table using the hand control. no patient injury or adverse health outcomes have been reported due to this issue.
  • Acción
    Should this occur, users are advised that the table can be relocked by pressing the Floor Lock button on the table hand control. As soon as parts are available a Device Technologies representative will contact customers to schedule the installation of new hardware and updated software on all affected Surgical tables. In addition, a new copy of the 4085 Surgical Table Operator Manual will be provided during this site visit. Users may continue to operate all 4085 series surgical tables prior to the completion of the update. This action has been closed-out on 19/08/2016.

Device

STERIS 4085, 4085 SS and 4085 Feather Weight Leg Section (FLWS) Surgical tables
  • Modelo / Serial
    STERIS 4085, 4085 SS and 4085 Feather Weight Leg Section (FLWS) Surgical tablesProduct Codes: ST-01-360-1, ST-01-380-1 and ST-01-360-7All batches manufactured between 3 July 2009 and 20 June 2014Multiple affected serial numbersARTG number: 149156
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd