Events

Rappel de V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation Systems Manufactured between 2 January 2014 and 2 May 2016

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia 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-00803-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-06-20
  • 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-00803-1
  • 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
    Steris has identified that v-pro 1, v-pro 1 plus, and v-pro max sterilisers manufactured after 1 january 2014 may not display the correct date as of 29 february 2016. while the v-pro units display an incorrect date, the steriliser functions and cycle operations continue to operate properly. if users do not manually change the system date of the v-pro unit, the unit’s display and cycle printout will contain an incorrect date.
  • Action
    Device Technologies is advising users that a service technician will be upgrading all affected systems. Users are advised that the system date can be amended using the instructions found in the Operator's Manual. The system can continue to be used as normal until corrected. This action has been closed-out on 11/05/2017.

Device

V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation Systems Manufactured between 2 Jan...
  • Modèle / numéro de série
    V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation SystemsManufactured between 2 January 2014 and 2 May 2016ARTG Number: 154905
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd