Events

Alerte De Sécurité sur 560P High Definition Camera Control Unit

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Smith & Nephew.

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
    2012-03-30
  • 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_20120330.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: smith & nephew 560p high definition camera control unit medical device manufacturer, smith & nephew inc., issued a field safety notice concerning certain 560p high definition camera control unit [product code: 72201919; serial no.: bbs1203 & bbs1450]. user of the device may experience intermittent loss of video due to a defective board component, which was incorporated during the manufacturing process. according to the manufacturer, there is a risk of inadvertent damage to non-target tissue while visualization is not functioning correctly if loss of video or display is experienced during the surgical procedure. according to the local supplier, the affected devices were distributed to hong kong. for more details, please refer to the attachment. if you are in possession of the product, please contact your supplier for necessary actions.

Device

560P High Definition Camera Control Unit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Smith & Nephew 560P High Definition Camera Control Unit
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew