Events

Alerte De Sécurité sur Syngo X-Workplace with software version VD10E

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..

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
    2016-03-16
  • Date de publication de l'événement
    2016-03-16
  • 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_20160316.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 syngo x-workplace with software version vd10e the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning syngo x-workplace with software version vd10e, manufactured by siemens. [catalogue numbers: 10094165, 10281299 and 10502522 when used in combination with carto systems]. according to the manufacturer, an issue can occur after the export of segmentation results of the left atrium created on syngo x workplace to an electro-anatomical 3d mapping carto system. after importing, the segmentation result appears mirrored at the carto system, and cannot be used for the ablation procedure. although unlikely, there is a risk of serious health effects if the incorrect image is used for ablation. the manufacturer is advising users that a software upgrade will be performed as a permanent correction. users are advised to stop using any segmentation result for export to the carto system until the software upgrade is performed. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00267-1 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 16 march 2016.

Device

Syngo X-Workplace with software version VD10E
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Siemens Syngo X-Workplace with software version VD10E
  • Manufacturer
    Siemens.

Manufacturer

Siemens.