Events

Alerte De Sécurité sur Ingenuity Core

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Philips.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2018-04-16
  • Date de publication de l'événement
    2018-04-16
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180416.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: philips ingenuity core the therapeutic goods administration (tga), australia posted a medical device safety alert concerning philips ingenuity core [model number: 728321; serial number: 333175]. the manufacturer has identified systems that may have been infected with the "wannacry" ransomware virus before installation. the virus may encrypt files in a way that: prevents system access; or a patient undergoing a scan or recently scanned whose results have not been reviewed may require a ct rescan; or during a biopsy the system may be slowed such that the operator is unable to visualise the advancement of a biopsy needle in real time. according to the manufacturer, there have been no reports of patient harm as a result of this issue. the manufacturer will contact the users to arrange an appointment for a field service engineer to correct the software on any potentially impacted systems for details, please visit the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00312-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2018.

Device

Ingenuity Core
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Ingenuity Core
  • Manufacturer
    Philips

Manufacturer

Philips
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH