Events

Rappel de Molift Air 205 and 300 ceiling hoist (a powered lifting device)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Patient Handling 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-2016-RN-00975-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-25
  • 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-2016-RN-00975-1
  • 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 a total of 4 reports where the bolt on the suspension coupling on molift air has become loose in the coupling. all reports came after technical testing and inspection. to date, no reports have been received regarding patient injury resulting from this issue. however, there is a potential risk for harm or injury if the bolt inside the coupling comes loose from the housing.
  • Action
    Patient Handling will arrange to upgrade the device with a retainer safety ring that will prevent the bolt within the suspension coupling coming loose. Qualified service personnel will install the upgrade kits on all affected systems. Consumers are advised to contact the place of purchase to organise a qualified service technician to install the upgrade kit. For more details, please see https://www.tga.gov.au/alert/molift-air-ceiling-hoist .

Device

Molift Air 205 and 300 ceiling hoist (a powered lifting device)
  • Modèle / numéro de série
    Molift Air 205 and 300 ceiling hoist (a powered lifting device)Molift Air 205Model Numbers: 2501205, 2501210, 2501215, 2501220Molift Air 300Model Numbers: 2501300, 2501310, 2501315, 2501320Distributed between May 2013 and January 2016ARTG Number: 229696
  • Manufacturer
    Patient Handling Pty Ltd

Manufacturer

Patient Handling Pty Ltd