Events

Rappel de ROHO High Profile and Mid Profile Single Compartment Cushion with Sensor Ready Technology

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Permobil Australia.

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-00400-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-07
  • 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-00400-1
  • 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
    A problem was discovered internally with a supplied component for the affected products listed above. when a smart check by roho (smart check), model number smartcheck-01, is used to perform a smart setup with one of the affected cushions, the nonconforming part may adversely affect the setup process resulting in an improper cushion setup. sitting on an over inflated or under inflated sensor ready cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.(please note that this risk is not present when the sensor ready cushion is used without the smart check nor is the risk present when the sensor ready cushion is used with the smart check and the setup is performed using the optional setup mode).
  • Action
    Permobil is advising users to return affected stock to their distributor. Distributors are requested to then contact Permobil to organise a replacement of the affected stock.

Device

ROHO High Profile and Mid Profile Single Compartment Cushion with Sensor Ready Technology
  • Modèle / numéro de série
    ROHO High Profile and Mid Profile Single Compartment Cushion with Sensor Ready Technology Multiple Model NumbersSerial Numbers between A2920163 and A3185287Production dates from 8 January 2016 to 28 February 2017ARTG Number: 111106
  • Manufacturer
    Permobil Australia

Manufacturer

Permobil Australia