Events

Alerte De Sécurité sur XR 6000 systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par GE 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
    2016-10-31
  • Date de publication de l'événement
    2016-10-31
  • 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_20161031.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: ge healthcare xr 6000 systems the health sciences authority (hsa) of the singapore has posted a medical device safety alert concerning xr 6000 systems, manufactured by ge healthcare. the manufacturer has recently become aware of a potential safety issue with the horizontal tube arm of the system used on xr 6000 systems. there has been a reported incident of a horizontal tube arm falling from the system. a fall of a tube arm suspending the collimator and tube apparatus could result in a serious injury or death to a patient or operator. a minor injury has been reported as a result of this issue. the manufacturer will correct the affected systems. the manufacturer recommends users not to use the xr 6000 system until they are corrected. for details, please refer to the hsa’s website: http://www.Hsa.Gov.Sg/content/hsa/en/health_products_regulation/medical_devices/product_owners_fsn/2016/september.Html if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 october 2016.

Device

XR 6000 systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare XR 6000 systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare