Events

Retiro De Equipo (Recall) de Steelco DS1000 Washer Disinfectors with an auto load/unload module attached(Instrument cleaner and disinfectors)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por In Vitro Technologies 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-00248-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-15
  • 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-00248-1
  • 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
    This action is further to the one in july 2016 (tga ref.: rc-2016-rn-00909-1) that was for all steelco washers with auto load/unload module. this issue relates to ds1000 washers, which need another s/w update. in regular operation, the photo optical sensor at the end of an unloading table would signal that a rack had reached the endpoint of its travel out of a washer chamber & send a command for the unloading arm to return to its home state position. if this sensor is somehow inadvertently obstructed/disturbed during the unloading process of the rack it has the potential to send a message to the invertor communicating with the plc that it hadn’t fully unloaded the rack. the system is not able to process the fact that it is unloading a rack at the same time the sensor is telling it that the rack had already been unloaded. this situation could cause an unwanted movement of the unloader arm, causing it to come into contact with the washer’s glass door & potentially causing it to break.
  • Acción
    In Vitro Technologies will be organising the installation of a software upgrade on the PLC of all DS1000 washers installed with unloaders. This software change will eliminate the incorrect closure of the machine door due to unintended obstruction of the optical sensors or external parts placed on the table.

Device

Steelco DS1000 Washer Disinfectors with an auto load/unload module attached(Instrument cleaner an...
  • Modelo / Serial
    Steelco DS1000 Washer Disinfectors with an auto load/unload module attached(Instrument cleaner and disinfectors)Model Number: DS1000 1SCatalogue Numbers: STCDS10001S_STEAM, STCDS10001S_MIXED, STCDS10001SR_STEAMModel Number: DS1000 2SCatalogue Number: STCDS10002S_MIXEDModel Number: DS1000 3SCatalogue Numbers: STCDS10003S, STC9930030; STCDS10003S_MIXED, STCDS10003S_STEAM ARTG Number: 206635
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd