Events

Alerte De Sécurité sur MLCi and MLCi2 radiation heads

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
    2012-04-20
  • 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_20120423a.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 mlci and mlci2 radiation heads medical device manufacturer, elekta limited, has issued a field safety notice concerning all mlci and mlci2 radiation heads. according to elekta, it is possible that the backup diaphragms drive mechanism can become loose after many years in clinical operation. this can cause a backlash between the positioning mechanism and the diaphragm. this backlash can be seen by the usual x-ray and field calibration checks when the field is moved from a small to a large field size. if there is a problem it will be that the backup diaphragm is not in the correct position behind the mlc leaf tips. if the affected customers do not do the recommended planned maintenance program, screws can become lost from the positioning mechanism. as the problem can lead to clinical mistreatment if it is not repaired, customers are advised to conduct a weekly recommended physics check of the x-ray and light field size calibration to make sure the field is moved from a small to a large field size. 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 for necessary actions.

Device

MLCi and MLCi2 radiation heads
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Elekta MLCi and MLCi2 radiation heads
  • Manufacturer
    Elekta Limited

Manufacturer

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