Events

Rappel de IMRIS ORT100 and ORT300 Operating Room Tables

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-2018-RN-00209-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-07
  • 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-2018-RN-00209-1
  • 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 imris ort100 and ort300 table rotational locking mechanism may experience a failure. the ort100 rotational locking mechanism can become disengaged or unlocked while in use, which could potentially result in unintended movement of the table due to the older lock design. the ort300 rotational lock may fail to operate such that it cannot change states between locked and unlocked as a result of actuator failure due to improper adjustment of the actuator or the linkage. there have been no reports of injury as a result of this issue.
  • Action
    Emergo is advising: - for users with ORT 100 tables: the rotational locking mechanism in all affected ORT 100 tables will be replaced with the most current design; - for users with ORT 300 tables: all customer sites with these tables shall have the rotational lock operation verified and adjusted, if necessary.

Device

IMRIS ORT100 and ORT300 Operating Room Tables
  • Modèle / numéro de série
    IMRIS ORT100 and ORT300 Operating Room TablesPart Numbers: 110470-000 and 114093-000Serial Numbers:10003241, 10002255ARTG Number: 276861(Emergo Asia Pacific - Table, x-ray system, diagnostic, general-purpose, powered)
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia