Events

Retiro De Equipo (Recall) de Hologic Altec Canister Lid

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Hologic Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    20495
  • Fecha de inicio del evento
    2016-08-11
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Pharmaco (NZ) Ltd, Level 1, 4 Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Causa
    Some of the lids of one particular lot of atec canisters may have cracks and therefore this specific lot number is being recalled, the issue will be discovered during the inspection of the canister during the 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.
  • Acción
    Product to be returned to supplier

Device

Hologic Altec Canister Lid
  • Modelo / Serial
    Model: , Affected: Lot No: 20150013
  • Manufacturer
    Hologic Inc

Manufacturer

Hologic Inc
  • Empresa matriz del fabricante (2017)
    Hologic Inc
  • Source
    NZMMDSA