Events

Retiro De Equipo (Recall) de Angiodynamics Accu2i pMTA Applicator- Hyperthermia system applicator

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 AngioDynamics Inc (US).

¿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
    21545
  • Fecha de inicio del evento
    2017-06-15
  • 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: Getz Healthcare Limited, 2/20 Beatrice Tinsley Crescent, Albany, Auckland
  • Causa
    Manufacturer is recalling the accu2i pmta hyeprthermia system applicator as a potential failure mode has been identified of the tubing coolant line developing a leak within the applicator system which causes a "high reflected power" fault condition that makes the applicator inoperable to deliver microwave energy., hazard 1: applicator will not deliver power due to high reflected power fault condition., hazard 2: applicator's cooling line leaks cooling fluid within the applicator shaft., while the specific failure mode of the applicator not delivering the desired microwave energy would not result in any direct harm, the inserted applicator would need to be removed.
  • Acción
    Product to be returned to supplier

Device

Angiodynamics Accu2i pMTA Applicator- Hyperthermia system applicator
  • Modelo / Serial
    Model: 900-600; 900-601; 900-602, Affected: Various Lot numbers
  • Manufacturer
    AngioDynamics Inc (US)

Manufacturer

AngioDynamics Inc (US)