Events

Rappel de Artis Systems running Artis VC1x software (Fluoroscopic angiographic diagnostic x-ray 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 Siemens 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-00966-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-13
  • 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-00966-1
  • 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
    Under certain conditions, x-ray release on artis system version vc1x may get blocked. thepotential malfunction may only occur if:a) the system is ready for operation, andb) the c-arm was moved into the so called "patient transfer position" for patient transfer (in this position x-ray is blocked), andc) at the same time the c-arm is in "patient transfer position", a hardware failure in the ias (image acquisition system) is occurring.If the c-arm is moved out of the "patient transfer position" (the problem with the ias was solved by the system itself), x-ray remains blocked.This issue is known to have only occurred on a single system in the field.
  • Action
    If the failure mode occurs, customers are advised to urgently manually switch the system OFF ("System shutdown") then switch the system back ON again. The failure mode cannot be generally rectified by either executing the "System Restart" or "Application Restart" functions. The supplement to the Operator Manual with the above information is enclosed with the customer letters. The problem will be resolved during the next service update.

Device

Artis Systems running Artis VC1x software (Fluoroscopic angiographic diagnostic x-ray system)
  • Modèle / numéro de série
    Artis Systems running Artis VC1x software (Fluoroscopic angiographic diagnostic x-ray system)ARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA