Events

Rappel de IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci Si Vision Cart System which is a robotic surgical system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-01127-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-12
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01127-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer, intuitive surgical has identified that the metalized coating on the is3000 hd lamp module (pn ins-950093-05) may be incompatible with the illuminator (pn ins-951183-06) control board, leading to a red preventive maintenance advisory (pma) that shows up on all monitors and cannot be dismissed by the user. in rare circumstances the illuminator may be damaged or the lamp module might not illuminate. there have been no reports of lamp failures associated with this issue.
  • Action
    Device Technologies is advising users that this issue does not affect lamps with plastic coating. Affected lamps with metal finish may continue to be used until a replacement is received. If an error message is displayed, users should contact their Device Technologies representative.

Device

IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci S...
  • Modèle / numéro de série
    IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci Si Vision Cart System which is a robotic surgical system)Part Number (PN): INS-950093-05ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd