Events

Rappel de ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (software version VC30A)

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-2014-RN-00563-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-29
  • 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-2014-RN-00563-1
  • 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
    When using the 9l4 transducer in combination with virtual touch quantification (vtq), the displayed mechanical index (ie, the ml value which reflects the risk of mechanical cavitation that could cause tissue damage) may be outside the stated tolerance of +/=15%. this occurs only between the depths of 2.5cm and 3.4cm. to date, no patient injury has been reported.
  • Action
    Users are advised that the MI values should be interpreted as relative information and used only to assist the operators in implementing the ALARA (As Low As Reasonably Achievable) principle during patient examinations. For systems with software version VC25, Siemens is updating the Instructions for Use regarding the tolerance of the Mechanical Index (MI) displayed values. For systems with software version VC30A, Siemens is updating the software. This action has been closed-out on 18/02/2016.

Device

ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (...
  • Modèle / numéro de série
    ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (software version VC30A)Catalogue numbers: 10041461, 10440017 and 10441730ARTG Number: 137563
  • Manufacturer
    Siemens Ltd

Manufacturer

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