Events

Alerta De Seguridad para Stereo Biopsy Device used with Mammomat Inspiration Mammography System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Siemens Ltd.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-09-29
  • Fecha de publicación del evento
    2014-09-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140929c.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Siemens Stereo Biopsy Device used with Mammomat Inspiration Mammography System
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd