Events

Rappel de Rigid Arm Supports(used as part of Posiboard-2 and Positrest)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par alphaXRT 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-01031-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-08-09
  • 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-01031-1
  • 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 manufacturer civco radiotherapy have identified that specific units of rigid arm supports may have a height difference of approximately 17mm compared to those manufactured after july 2012.Due to the potential height variation in the rigid arm supports there is potential for mistreatment if there are multiple devices in the facility with varying heights between simulation and treatment. changes in arm position due to variation will impact the position of the chest wall and breast position. a 16.8mm variation in arm positioner could result in chest/breast/heart position changes which exceed expected treatment planning margins.
  • Action
    alphaXRT is requesting Customers: 1. If your facility has an affected device and a newer device which is not included in the list, then usage should be immediately suspended; 2. Complete the supplied customer acknowledgment form and return it to NP@alphaXRT.com; 3. Retain a copy of the Customer Letter along with your most current product labelling; 4. Ensure relevant staff members are informed of this recall including relevant clinicians who may need to monitor for adverse events. 5. Place the notification letter in a prominent position for at least one month.

Device

Rigid Arm Supports(used as part of Posiboard-2 and Positrest)
  • Modèle / numéro de série
    Rigid Arm Supports(used as part of Posiboard-2 and Positrest)Reference Numbers: 106047, 106015Lot Numbers: M164340, M178170, M165430, M165440, M191710 and M192470ARTG Number: 149575
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    alphaXRT Pty Ltd

Manufacturer

alphaXRT Pty Ltd