Events

Rappel de Allen Patient Supports

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Allen Medical Systems Inc.

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
    22277
  • Date de mise en oeuvre de l'événement
    2017-11-23
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Denyers (NZ) Ltd, 27 William Pickering Drive, Albany, Northshore, Auckland 0742
  • Cause
    The manufacturer has become aware of a potential risk, which could result in critical harm to the patient if the base of the bow frame were to crack during use. since the introduction of this product in march 2017, one complaint with no allegation of injury has been reported where the base of the frame cracked as the patient was being prepared for surgery.
  • Action
    Product to be modified

Device

Allen Patient Supports
  • Modèle / numéro de série
    Model: , Affected: Serial number range: A402596 thru A543137
  • Manufacturer
    Allen Medical Systems Inc

Manufacturer

Allen Medical Systems Inc