Events

Rappel de Runyes Autoclave17L, 22L B Class Manufactured between 2012 & 2017

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medical Equipment 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-2018-RN-00001-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-12
  • 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-2018-RN-00001-1
  • 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
    Medical equipment australia has been made aware of an issue regarding the failure of cycles when the negative pressure is not within a specified range. affected devices will be provided with a software update to rectify the issue of monitoring critical parameters during a cycle and generate a 'fail' if they are not reached.
  • Action
    Medical Equipment Australia will arrange a service technician to be in contact with users to arrange for software upgrade to correct this issue. In the interim, users should refer to the tests outlined in the customer letter to verify that their equipment is functioning correctly.

Device

Runyes Autoclave17L, 22L B Class Manufactured between 2012 & 2017
  • Modèle / numéro de série
    Runyes Autoclave17L, 22L B ClassManufactured between 2012 & 2017Multiple Affected Serial NumbersARTG Number: 197900 (Medical Equipment Australia Pty Ltd - Sterilizer, moist heat, fluid)
  • Manufacturer
    Medical Equipment Australia Pty Ltd

Manufacturer

Medical Equipment Australia Pty Ltd