Events

Rappel de Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging 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-2014-RN-01113-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-23
  • 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-01113-1
  • 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 reports of unintended radial motion of the detectors. this unintended motionmay cause the patient, compression related injuries. the symbia s or t system has been designed to detect such faults and automatically shut down. if the system shuts down with the message "system requires service, please contact your customer service representative" the system will be disabled until the error is manually cleared during service there have been no reports of injury as a result of this potential motion.
  • Action
    A Siemens local service engineer will contact customers to perform the inspection and schedule any necessary repairs to the affected systems. Siemens is advising that while waiting for the inspection to be performed, customers can continue to use their systems by adhering to the Cautions and Warnings in the user's manual and observing the patients during studies. This action has been closed-out on 08/08/2016.

Device

Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging system)
  • Modèle / numéro de série
    Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging system)Catalogue numbers: 8717733, 8717741, 10275007, 10275008, 10275009 & 10275010ARTG numbers: 123883 & 186317
  • Manufacturer
    Siemens Ltd

Manufacturer

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