Events

Rappel de Siemens e.cam Systems (Nuclear medicine gamma camera)

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-2015-RN-00657-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-07-17
  • 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-2015-RN-00657-1
  • 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 received a report of unintended detector motion. the cause of this motion was determined to be the simultaneous failure of two components, the radial brake circuit and touch pad. this unique combination of failures caused the axis brake to be ineffective, which ultimately led to the detector motion. additionally, activating the emergency stop (e-stop) or a system power failure, between 0.05 and 0.1 seconds after initiating motion could lead to this failure. siemens has determined that the likelihood that these events would occur over such a small time window is extremely rare. the most likely condition that could lead to a rapid power cycling is a touch pad failure. there have been no reports of injury as a result of this issue; however, it is remotely possible that a compression injury to the patient could occur.
  • Action
    -PRODUCT CORRECTION Siemens has designed and will install an improved brake control circuit which will correct this condition. Users are advised that the e-stop should still be used confidently and they can continue to use their system with confidence while waiting for the repair to be scheduled and performed. Users are reminded that daily touch test and/or its failure should not be ignored. If they experience difficulty or a failure while performing the daily touch pad test, discontinue use and contact their local service representative. This action has been closed-out on 05/09/2016.

Device

Siemens e.cam Systems (Nuclear medicine gamma camera)
  • Modèle / numéro de série
    Siemens e.cam Systems (Nuclear medicine gamma camera) Multiple catalogue numbers installed prior to December 31st 2004 affectedPart numbers: 4380213, 4380221, 5242826, 5977066, 5989079, 5991109, 5992099, 7324143, 7823946, 7823953. ARTG number: 186317
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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