Events

Rappel de C- Series lifts Manufactured between April 25, 2017 and June 12, 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 CHS Healthcare 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-01450-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-13
  • 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-01450-1
  • 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
    During internal cycle testing of c-series lifts handicare has found that the c-series lift strap for lifts manufactured between april 25, 2017 and june 12, 2017 may wear prematurely at max load (625 lbs). we have identified the root cause as a supplied component that was not to specification. if the strap wears during use there is a potential risk for the person being supported by the lift to drop.This issue was identified internally. to date, chs is not aware of any c-series lift strap incidence related to this issue.
  • Action
    CHS Healthcare will be in contact with affected customers to arrange removal of the current hoist and reinstall of a new unit.

Device

C- Series lifts Manufactured between April 25, 2017 and June 12, 2017
  • Modèle / numéro de série
    C- Series liftsManufactured between April 25, 2017 and June 12, 2017ARTG 292642
  • Manufacturer
    CHS Healthcare Pty Ltd

Manufacturer

CHS Healthcare Pty Ltd