Events

Notificaciones De Seguridad De Campo acerca de ATEC Sapphire Breast Biopsy System.

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Hologic, lnc..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    There have been reports of customers receiving atec canisters with cracked lids. we wanted to notify you that hologic is aware of the issue and we need your assistance resolving this problem. hologic inc. is recal ng certain lots of its atec canister. this ac n is being taken because the canister d may have cracks. the lot numbers affected by the reca are as follows: lot # 20150013 & 20150014. this issue will be discovered during the inspection of the canister during setup or via a system vacuum error when testing the eviva or atec biopsy needle. this issue does not pose any potential patient harm or other safety issue. however, it may prevent the system from enabling a procedure to continue.

Device

ATEC Sapphire Breast Biopsy System.

Manufacturer

Hologic, lnc.