Events

Rappel de Accent SR RF

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 St Jude Medical (USA).

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
    21880
  • Date de mise en oeuvre de l'événement
    2017-08-31
  • 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: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Cause
    The manufacturer is advising of the availability of new pacemaker firmware (a type of software) that is intended to address the risk of unauthorized access to pacemakers that utilize radio frequency (rf) communications (i.E., accent™/ anthem™, accent mri™/ accent st™, assurity™/ allure™ and assurity mri™). this firmware update provides an additional layer of security against unauthorized access to these devices that further reduces the potential for a successful cybersecurity attack.
  • Action
    Software to be upgraded

Device

Accent SR RF
  • Modèle / numéro de série
    Model: , Affected: Update for Accent/ Anthem, Accent MRI/ Accent ST, Assurity/ Allure and Assurity MRI devices
  • Manufacturer
    St Jude Medical (USA)

Manufacturer

St Jude Medical (USA)
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NZMMDSA