Events

Rappel de DRX Revolution Mobile X-Ray System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Carestream Health 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-2017-RN-00085-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-24
  • 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-00085-1
  • 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
    Carestream health australia pty ltd has received a report of unintended motion of a drx revolution mobile x-ray system caused by a loose pivot screw in the drive handle. there was no resulting injury. no other reports of this type have been received since the device was introduced into commercial distribution in 2009, however this problem could manifest itself in additional units over the lifetime of the device. if this failure was to recur in the field, the likelihood of injury would be mitigated by both bump stop and estop systems on the device – which the driver/operator could use. however, given the weight of the device and the speed at which it can travel, should the device make contact with a person, the subsequent collision or crushing injury could be serious e.G. fractured/broken bones.
  • Action
    Carestream is advising users that they will be inspecting affected serial numbers and replacing the lower handle assembly and internal side covers of the device. In the interim, the device can continue to be used; however it is recommended that routine user inspections of the drive are continued and should any part show a visual problem or fail to operate as expected, the device should be removed from use and a service call placed to Carestream. This action has been closed-out on 01/03/2018.

Device

DRX Revolution Mobile X-Ray System

Manufacturer

Carestream Health Australia Pty Ltd