Events

Alerte De Sécurité sur Precise Digital Accelerator, Synergy Platform, Synergy, Synergy S, Infinity, Axesse (Various Models, All lot no.)

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

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
    2011-12-14
  • 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_20111214a.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
    Field safety notice: elekta precise digital accelerator, synergy platform, synergy, synergy s, infinity, axesse (various models, all lot no.) medical device manufacturer, elekta limited, has issued a field safety notice on precise digital accelerator, synergy platform, synergy, synergy s, infinity, axesse, linear accelerator systems. a small number of reverse modulator diodes, a component in the equipment room of the linear accelerator, have ruptured. customers have heard a loud explosion in the equipment room sometime after beam termination. the patient and clinical operators are not at risk. a service engineer, or any personnel entering the equipment room could sustain serious injury. elekta reported that no incidents involving personnel have occurred. elekta has communicated with the users about the fitting of a reverse diode cover and advised that personnel who enter the equipment room should wear protective safety glasses before the cover is fitted. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier.

Device

Precise Digital Accelerator, Synergy Platform, Synergy, Synergy S, Infinity, Axesse (Various Mode...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Elekta Precise Digital Accelerator, Synergy Platform, Synergy, Synergy S, Infinity, Axesse (Various Models, All lot no.)
  • Manufacturer
    Elekta Limited

Manufacturer

Elekta Limited
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    DH