Events

Rappel de Standard SlingBar 450Distributed between January 1980 and November 2012

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-00477-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-09
  • 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-00477-1
  • 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
    Hill-rom has become aware of a safety issue related to the standard slingbar 450, which could be attached to various liko overhead and mobile lifts. a serious injury to a patient, caregiver, or bystander could result from tripping or otherwise falling in to the slingbar, typically while the lift is parked or stored when not in use. the sling hook on the other end of the sling bar could pierce a body structure such as the head, shoulder, or groin.
  • Action
    Hill-Rom is providing customers with a sling-bar safety cover to mitigate the risk of patient or user injury. For more details, please see http://www.tga.gov.au/safety/alerts-device-standard-slingbar-450-131001.htm .

Device

Standard SlingBar 450Distributed between January 1980 and November 2012
  • Modèle / numéro de série
    Standard SlingBar 450Distributed between January 1980 and November 2012Product numbers: 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043 & 5019013These product numbers may be bundled with the Golvo 1000, 3000 and 7000 series lifts, Viking M, Viking L, LikoLight 100 and 125, Caroli 101, and Uno 100, 101 and 102ARTG Number: 188199
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd