Events

Alerte De Sécurité sur Stereo Biopsy Device used with Mammomat Inspiration Mammography 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
    2014-09-29
  • Date de publication de l'événement
    2014-09-29
  • 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_20140929c.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 stereo biopsy device used with mammomat inspiration mammography system the australia therapeutic goods administration (tga), has issued a medical device safety alert concerning stereo biopsy device used with mammomat inspiration mammography system [material number: 10140000], manufactured by siemens ltd. the stereo biopsy devices for mammomat inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. the pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. the needle positioning device may move even with the safety switch being set sideward. if this occurs with the needle being already inserted, it could lead to an unintentional patient injury. affected users are advised that in case the needle holder moves unintentionally to press the emergency stop. the manufacturer is recommending inspection of the safety switch before every biopsy until the problem is solved. furthermore, it is preparing a modification of the safety switch. for details, please refer to the following tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01040-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 sep 2014.

Device

Stereo Biopsy Device used with Mammomat Inspiration Mammography System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Siemens Stereo Biopsy Device used with Mammomat Inspiration Mammography System
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd