Events

Alerte De Sécurité sur brilliance ct 64, ingenuity core and ingenuity core128 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
    2013-05-03
  • Date de publication de l'événement
    2013-05-03
  • 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_20130503.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 brilliance ct 64, ingenuity core and ingenuity core128 systems medical device manufacturer, philips healthcare issued a medical device safety alert concerning all brilliance ct 64, ingenuity core and ingenuity core128 systems using software versions 2.6.1 or 3.5.4. philips healthcare received reports from the field that certain brilliance ct 64, ingenuity core and ingenuity core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. philips healthcare states that there are no proactive actions for the user. clinical judgment should be used by the customer or user to determine if the images contained in the dataset without artifacts contain enough information to make a diagnosis. if these images are sufficient, no further action is required. if the images are not sufficient, a rescan of the patient is required. philips healthcare is implementing software update versions 2.6.2 or 3.5.5 to correct the above-described issue. according to the local supplier, philips electronics hong kong ltd, 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 3 may 2013.

Device

brilliance ct 64, ingenuity core and ingenuity core128 systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Brilliance CT 64, Ingenuity Core and Ingenuity Core128 systems
  • Manufacturer
    Philips Healthcare

Manufacturer

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