Events

Alerte De Sécurité sur Symbia T Series and Symbia Intevo Camera System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Siemens Ltd.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-08-12
  • Date de publication de l'événement
    2014-08-12
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140812a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: siemens symbia t series and symbia intevo camera system the australia therapeutic goods administration (tga) posted a medical device safety alert concerning symbia t series and symbia intevo camera system manufactured by siemens ltd. the manufacturer recently detected a rubber isolator with unfavourable aging properties. the function of this rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. in rare cases, when unfavourable aging has occurred, the rubber isolator may break and cause loss of support for the rotate motor. this event could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient. the possibility of a serious injury does exist if the belt makes contact with the patient. the manufacturer advises customers that they can continue to use the systems while waiting for the corrective action to be undertaken which includes new mounting plate with improved rubber components and a backup device to ensure trouble free operation in the future. users are advised to immediately discontinue use of the affected product and contact their service engineer if they are experiencing abnormal noise or vibration. users are also asked to ensure that the safety advisory is placed in the system owner's manual. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00881-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 august 2014.

Device

Symbia T Series and Symbia Intevo Camera System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Siemens Symbia T Series and Symbia Intevo Camera System
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd