Events

Rappel de Ceiling Supply Units (CSU) 80xx/CSU60xx (Used for positioning of medical gas and vacuum systems)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Draeger Medical 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-2013-RN-00838-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-16
  • 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-2013-RN-00838-1
  • 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 manufacturer has received reports where the drive screw in the motor unit, which lifts and lowers the lower lift arm broke. as a result, the lift arm fell down approximately 60cm (23.6 inches). if the drive screw breaks, personnel standing under the ceiling supply unit (csu) may be injured or objects damaged.
  • Action
    Draeger will be performing an inspection of affected devices to identify potential fractures of the drive screw during the next maintenance cycle. If a user does not have a service contract with Draeger, an inspection can be commissioned or alternatively, the end user's technical department can carry out the inspection by following the maintenance instructions provided with the recall letter.

Device

Ceiling Supply Units (CSU) 80xx/CSU60xx (Used for positioning of medical gas and vacuum systems)
  • Modèle / numéro de série
    Ceiling Supply Units (CSU) 80xx/CSU60xx (Used for positioning of medical gas and vacuum systems)ARTG Number: 132260
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd