Events

Alerte De Sécurité sur Pinnacle3 software

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 Healthcare.

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
    2013-05-08
  • Date de publication de l'événement
    2013-05-08
  • 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_20130508c.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 pinnacle3 software medical device manufacturer, philips healthcare issued a field safety notice concerning all pinnacle3 software with versions 9, 9.2, and 9.4. a problem has been detected in the philips pinnacle3 software that, if it were to re-occur, could affect the performance of the equipment. under certain conditions in pinnacle3 9, 9.2, and 9.4, users can modify the geometry of a beam or change the parameters for a bolus and the software does not invalidate the control point dose. philips healthcare is distributing an addendum to the pinnacle3 instructions for use (ifu) which describes how to explicitly invalidate control point dose in this situation. the underlying issue is corrected in pinnacle3 9.6. the manufacturer recommends customers to review the information contained in the notice including the ifu addendum with all members of the staff who need to be aware of their contents and retain a copy of the addendum with the pinnacle3 9, 9.2, and 9.4 ifu. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

Pinnacle3 software
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Pinnacle3 software
  • Manufacturer
    Philips Healthcare

Manufacturer

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