Events

Rappel de IMRIS Operating Room table (ORT300)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo 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-2014-RN-01078-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-10-07
  • 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-2014-RN-01078-1
  • 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
    Emergo australia is replacing the table alignment block pins, which are currently made from ferrous materials, with pins made from non-ferrous material due to an incident at a health care facility in the united states. one of the three pins that is used to hold the ort200 table alignment block in place on the floor of the mr suite went missing and was not accounted for by or personnel. during testing the missing pin was pulled into the magnet, damaging the image quality phantom and headrest extension. no injury or death occurred as a result of this incident.
  • Action
    Emergo Australia is replacing the table alignment block pins, which are currently made from ferrous materials, with pins made from non-ferrous material. A field engineer will be sent to the customer site to replace the pins. This action has been closed-out on 06/06/2016.

Device

IMRIS Operating Room table (ORT300)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia