Events

Alerte De Sécurité sur brightview xct

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Philips 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
    2013-09-09
  • Date de publication de l'événement
    2013-09-09
  • 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_20130909.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: philips brightview xct the therapeutic goods administration (tga), australia posted a medical device safety alert concerning brightview xct manufactured by philips healthcare (model numbers 882482 and 882454). philips received a report from the field that the flat panel detector (fpd) sensor reported to the operator that the panel was unlatched at the zero degree position during setup. the operator attempted to manually relatch the fpd as it remained in the zero degree position. in trying to restow the fpd, it fell from its stowed position and contacted the patient's leg and the technologist's arm. the manufacturer advises customer to keep the fpd in the deployed position until the implementation of the appropriate field safety correction. for details, please refer to tga website http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00944-1 if you are in possession of the product, please contact your supplier for necessary actions. posted on 9 september 2013.

Device

brightview xct
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips BrightView XCT
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH