Events

Rappel de ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware and Auxiliary (AUX IN/OUT) cable

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-2018-RN-00241-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-26
  • 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-2018-RN-00241-1
  • 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 that in some cases the ecg signal may flatline due to electromagnetic interference when used in conjunction with electrosurgical equipment. the electrosurgical equipment creates electromagnetic interference (emi) which is then transmitted to the physio module and the sc2000 system through the aux in/out cable. this interference causes the system to lose communication with the physio module. to date, there have been no reported injuries as a result of this issue.
  • Action
    Siemens is advising: If the ECG trace disappears or flatlines, perform the following steps to disable the ECG trace and exit the physio module functionality: 1. Press F13 (Physio) on the keyboard. 2. Press the scroll wheel to select the appropriate ECG or AUX trace option and then press the Off soft key. 3. To exit the Physio menu, press F13 (Physio) again. After these steps are performed, the ultrasound system will use time-based captures instead of beat captures. Also note that the system may be rebooted to reset the ECG trace. However, if the electrosurgery equipment is used again the symptom will reoccur. This issue will be resolved by a hardware update to affected systems. Siemens Customer Service will contact users to schedule this replacement if the system configuration is affected by the scope of this issue.

Device

ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware...
  • Modèle / numéro de série
    ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware and Auxiliary (AUX IN/OUT) cableCatalogue number: 10433816ARTG Number: 139591Siemens Healthcare - Ultrasound system, imaging, cardiovascular
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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