Events

Rappel de Ceiling Unit CU5001/3 and CU 3-21/23

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-2017-RN-01286-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-13
  • 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-2017-RN-01286-1
  • 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
    The microscope arm of specific ceiling units can be electrically driven from the parked position into the operating field by an electromotive lifting column. the manufacturer moller-wedel has identified that abrasive wear of the drive assembly can occur which could cause a slide-through of the telescopic column into the lowest stop.The microscope arm can be moved upwards and downwards with a levitation height of 40cm by a motorised adjusted telescopic column. if severe abrasive wear occurs the lifting column can slide downwards during lifting procedures up to 40cm onto the lowest stop.
  • Action
    Device Technologies is advising users to move the telescope column to the lowest position for use without restrictions. Users should attach provided labels to the ceiling unit to indicate that the lifting column is in the lowest position until service has been performed.

Device

Ceiling Unit CU5001/3 and CU 3-21/23
  • Modèle / numéro de série
    Ceiling Unit CU5001/3 and CU 3-21/23Product Code: CU 5001Reference Number: 604 105Serial Numbers: from P51 up to 274Product Code: CU 5003Reference Number: 604 106Serial Numbers: from P51 up to 127Product Code: CU 3-21Reference Number: 604 650Serial Numbers: from P51 up to P58Product Code: CU 3-23Reference Number: 604 700Serial Numbers: from P51 up to P60ARTG Number: 267878
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd