Events

Rappel de GETINGE WD15 Claro - Washer Disinfector

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Getinge 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-00829-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-27
  • 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-00829-1
  • 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
    Getinge have identified a possible water leakage on limited washer disinfectors of model type wd15. if this issue occurs, both an acoustic and visual alarm ("a03 over flow co" on the machines display) will be present. this leakage may take place during operation in the last part of the cleaning and disinfection cycle. the leaking water has not been processed through the machine and from investigations it does not make contact with critical electrical components of the washer.If the issue is left unattended, there can be a leakage of cold water out from the water supply to the machine (up to 2 l/min). if users do not respond to the alarm, there may be a significant amount of water on the floor which may result in a person falling and acquiring an injury. there is also a risk for property damage from the water leak.To date, no injuries have been reported as a result of this issue.
  • Action
    Getinge are advising they are investigating this issue and will provide a solution as soon as it becomes available. In the interim, users may continue to use the washer, provided that the machine is not left unattended. Users should react to device alarms immediately. If an alarm *A03 OVER FLOW CO* is activated, users are advised to do the following; 1. Switch off the main switch; 2. Close shut off valves in the water supply lines; and 3. Contact a service technician.

Device

GETINGE WD15 Claro - Washer Disinfector
  • Modèle / numéro de série
    GETINGE WD15 Claro - Washer DisinfectorSerial Numbers: WAA083548 and WAA082736ARTG Number: 125655(Getinge Australia Pty Ltd - Washer, decontamination, utensil)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA