Events

Rappel de Shuttle Discovery Seat (designed for children aged between six months and four years who have a physical disability)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medifab 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-2015-RN-00951-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-30
  • 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-2015-RN-00951-1
  • 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
    Medifab have identified two safety issues relating to the backrest and the tilt in space locking plunger on shuttle discovery.1. on some discovery seats the rear “s tubes” are moving in and out excessively when the backrest is rocked backwards and forwards. although some movement is normal, there is potential for the s tubes to come out of the mounting block should the motor vehicle used to transport the end user in the discovery buggy be involved in an accident. 2. on some discovery seats the tilt in space plungers are not engaging in the plastic sides. there is potential that the discovery seat may tilt back should the motor vehicle used to transport the end user in the discovery buggy be involved in an accident. there have been no reported incidents in relation to these issues.
  • Action
    A Technician or Product Consultant will contact customers to arrange a suitable time to carry out the corrective actions. For more details, please see https://www.tga.gov.au/alert/shuttle-discovery-seat . This action has been closed-out on 28/02/2018.

Device

Shuttle Discovery Seat (designed for children aged between six months and four years who have a p...
  • Modèle / numéro de série
    Shuttle Discovery Seat (designed for children aged between six months and four years who have a physical disability)Product Code: 2006-0010-000Batch #: JS-06-14-DS-**JS-15-14-DS-** JS-18-14-DS-**JS-23-14-DS-**, JS-45-14-DS-**JS-46-14-DS-**ML-8-15-DS-**ML-13-15-DS-**ML-16-15-DS-** ML-17-15-DS-**ML-18-15-DS-**6142761738ARTG #: 160111
  • Manufacturer
    Medifab Ltd

Manufacturer

Medifab Ltd