Events

Alerte De Sécurité sur SL75/5 Linear Accelerator

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.

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
    2012-08-29
  • Date de publication de l'événement
    2012-08-29
  • 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_20120829.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: elekta sl75/5 linear accelerator the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning all sl75/5 linear accelerator, manufactured by elekta. according to the manufacturer, there was malfunction of the semikron diode of sl75/5. this diode is fitted as charging diode d8 but can also be fitted as reverse diode d7 on later machines. they can be found on the modulator chassis assembly. if a malfunction of the semikron diode occurs, the ceramic body of the diode can rupture. this can cause ceramic material and silicone oils to eject from the modulator assembly which may cause injury to on-site service personnel. there are currently no reported incidents of this kind on sl75/5 machines. furthermore, the manufacturer recommends that: service personnel should always wear protective safety glasses, when they do work on the modulator assembly with the covers removed. users should make sure the door of the modulator chassis assembly is closed when the digital accelerator is in operation. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 august 2012.

Device

SL75/5 Linear Accelerator
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Elekta SL75/5 Linear Accelerator
  • Manufacturer
    Elekta

Manufacturer

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