Events

Alerte De Sécurité sur acuson sc2000 ultrasound systems

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
    2014-01-07
  • Date de publication de l'événement
    2014-01-07
  • 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_20140107a.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 acuson sc2000 ultrasound systems the australia therapeutic goods administration (tga) posted a medical device safety alert concerning acuson sc2000 ultrasound systems manufactured by siemens ltd. according to the manufacturer, the user interface module on the ultrasound system consists of the console (monitor, control panel and keyboard) and the swivel mechanism.The swivel mechanism is used for adjusting the height and rotation of the console and is attached to the column on the ultrasound system. if the connection of the user interface module to the column on the ultrasound system is loose, the entire module may fall off the ultrasound system resulting in injuries. the manufacturer advises end users to inspect their units for any looseness in the attachment of the interface module to the column on the ultrasound system. if looseness is observed, the user should discontinue use of the device immediately and contact the manufacturer. a service engineer will perform the necessary repairs. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00005-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 january2014.

Device

acuson sc2000 ultrasound systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Siemens ACUSON SC2000 Ultrasound Systems
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd