Events

Rappel de Ceiling mounted rail systems for Liko Overhead Lifts

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Hill-Rom 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-01330-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-01-16
  • 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-01330-1
  • 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 issue relates to fasteners securing overhead lift rail systems to ceilings in chlorinated indoor pool applications. two complaints with no confirmed injuries have been reported to hill-rom that corrosion of the fasteners could lead to the rails becoming unattached and falling. hill-rom’s analysis has concluded that the root cause is stress corrosion cracking (scc) on the stainless steel hardware may occur in the presence of chlorinated environments such as swimming pool areas. there is a risk that continued use of the stationary lift in a chlorinated pool area could result in injuries to patients, caregivers or bystanders.
  • Action
    Hill-Rom is advising users that an inspection will be carried out on all potentially affected systems located in a chlorinated environment and if systems are found to be of stainless steel hardware, it will be replaced with unaffected hardware. Hill-Rom is reminding users that periodic inspections are required for the rail systems in accordance with the Instructions for Use (IFU). For more details, please see http://www.tga.gov.au/safety/alerts-device-liko-overhead-lifts-140121.htm . This action has been closed-out on 11/02/2016.

Device

Ceiling mounted rail systems for Liko Overhead Lifts

Manufacturer

Hill-Rom Pty Ltd