Events

Alerte De Sécurité sur Apex Collimator

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
    2013-02-05
  • Date de publication de l'événement
    2013-02-05
  • 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_20130205a.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 apex collimator the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning apex collimator manufactured by elekta limited. according to the manufacturer, if the apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates. the inhibit may or may not show in the tcs restrictions list in the view restrictions dialog box, but it still prevents the machine movements. if the touchguard button is used to override the inhibit and rotate the gantry, the apex collimator may disconnect from the radiation head and cause serious injury and damage to the equipment. elekta recommends the users to follow the advice as mentioned in the field safety notice to solve the problem. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con226996 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 february 2013.

Device

Apex Collimator
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Elekta Apex Collimator
  • Manufacturer
    Elekta Limited

Manufacturer

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