Events

Rappel de Steelco Washer Disinfectors (Instrument cleaner and disinfectors) All Steelco washers with an auto load/unload module attached

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par In Vitro Technologies Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00909-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00909-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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 and send a command for the unloading arm to return to its home state position. if this sensor is somehow inadvertently obstructed or 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. in this situation it could cause an unwanted movement of the unloader arm, causing it to come into contact with the washer’s glass door and potentially causing it to break.
  • Action
    In Vitro Technologies will be organising the installation of a software upgrade on all loading and unloading modules. The software change will prevent the system faulting due to unintended obstruction of the unloader sensors.

Device

Steelco Washer Disinfectors (Instrument cleaner and disinfectors) All Steelco washers with an aut...
  • Modèle / numéro de série
    Steelco Washer Disinfectors (Instrument cleaner and disinfectors)All Steelco washers with an auto load/unload module attachedCatalogue Numbers: STC9935022, STC99911173, STC9991133, STC9995007, STCC210, STCC211, STCC228ARTG Number: 206635
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd