Events

Rappel de MAQUET operating table accessories with Accessory Adaptor 600525A0 Manufactured from 2002 onwards

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Maquet Australia 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-01225-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-15
  • 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-01225-1
  • 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 accessory adaptor (600525a0) is designed for the mounting of maquet accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment. the accessory adapter is used with the magnus table back plates to attach the horseshoe head rest or the skull clamp. maquet has been notified of a case where a head rest was levered out of the dovetail profile of the accessory adaptor. it was identified that the raw material of the accessory adaptor did not meet maquet specifications. while the accessory adapter does carry the specified weight of 11kg at a distance of 300mm, the tensile and flexural strength of the material was less than specification.There is a very rare possibility should the attached accessory release from the adapter without warning during a surgical procedure that the patient may sustain a cervical spine injury. to date no incident has been reported in which a person was injured.
  • Action
    MAQUET will be contacting customers to provide a new replacement Accessory Adaptor (600525A0). Until the replacement has been provided, MAQUET is advising users that Accessory Adaptor (600525A0) should not be used.

Device

MAQUET operating table accessories with Accessory Adaptor 600525A0 Manufactured from 2002 onwards
  • Modèle / numéro de série
    MAQUET operating table accessories with Accessory Adaptor 600525A0 Manufactured from 2002 onwardsARTG Number: 163023
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA