Events

Rappel de ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging 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 ConMed Linvatec 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-00224-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2013-03-12
  • 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-00224-1
  • 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 has determined there is potential for the keyboard to lockup during operation due to a software issue in the vp1600 console. if during use the caps lock/num lock is pressed, the vp1600 software could potentially give the appearance of being locked up, but is actually unresponsive only to keyboard inputs. the vp1600 is still presenting a live image on the main display but may not be able to capture an image frame for record storage using the keyboard.
  • Action
    Please contact ConMed Linvatec Australia to schedule a return date for repairing the affected unit. A loan unit will be provided by ConMed Linvatec if needed during the repair. VP1600 can continued to be used until repaired if the manufacturer’s recommendations and instructions detailed in the Product Manual, for the safe handling and use of the device is followed.

Device

ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system)
  • Modèle / numéro de série
    ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system)Affected Serial numbers: 75659, 75804, 76126, 75805, 76116, 12008, 72902, 76009, 12043, 12036, 75657, 75658 and 12015ARTG: 126243
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd