Events

Rappel de ACUSON S Family ultrasound systems with software versions VD10A or VD10C when using 18L6 HD transducer

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 Healthcare 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-2017-RN-00478-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-19
  • 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-2017-RN-00478-1
  • 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
    Siemens has identified a potential issue with the 18l6 hd transducer on the acuson s family ultrasound systems (with software versions vd10a or vd10). when scanning with the 18l6 transducer on the acuson helx evolution with touch control, the ultrasound system may display a triple image or an image with a dark band. when the triple image issue occurs, the system repeats one-third of the aperture, but does not display the full field of view. the issue occurs intermittently when connecting the 18l6 hd transducer to the ultrasound system or when selecting the touch screen control to activate the transducer. the potential risk is specific to breast exams and the possibility of not visualising lesions when acquiring images of breast tissue, which may result in a misdiagnosis.
  • Action
    Siemens is recommending users perform the following steps before using the18L6 HD transducer: Connect the transducer to the ultrasound system and place a gel-coated fingertip on the transducer face. Drag the finger along the entire face of the transducer and if the echo from the finger displays in triplicate, disconnect and reconnect the transducer. Then repeat the test. It is recommended that users review any breast studies performed with an affected device to confirm no triple images were used as part of a diagnosis. Siemens is advising users that steps have been taken to resolve the issue with a software release.

Device

ACUSON S Family ultrasound systems with software versions VD10A or VD10C when using 18L6 HD trans...
  • Modèle / numéro de série
    ACUSON S Family ultrasound systems with software versions VD10A or VD10C when using 18L6 HD transducerCatalogue Numbers: S1000 – 10441701S2000 – 10041461S2000 (Refurbished) – 10440017S3000 – 1044173018L6 HD Transducer - 10041227 & 10789400ARTG Number: 137563
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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