Events

Alerte De Sécurité sur ingenia 1.5t and ingenia 3.0t magnetic resonance 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 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
    2014-01-30
  • Date de publication de l'événement
    2014-01-30
  • 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_20140130.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 ingenia 1.5t and ingenia 3.0t magnetic resonance systems medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its ingenia 1.5t and ingenia 3.0t magnetic resonance systems [identification numbers: 989603019151, 989603019152, 989603019153, 989603019211, 989603019212 & 989603019213]. according to the manufacturer, under certain conditions, it is possible that the ingenia tabletop gets obstructed and is slowed or halted before it has been fully moved out of the magnet. users may continue to use the system, but in the event that the tabletop becomes blocked, the manufacturer should be contacted for repair. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 january 2014.

Device

ingenia 1.5t and ingenia 3.0t magnetic resonance systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Ingenia 1.5T and Ingenia 3.0T Magnetic Resonance systems
  • Manufacturer
    Philips Healthcare

Manufacturer

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